Job Board

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Please review the BWICR job posting price list here

AVAILABLE JOBS

Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.

Westat is committed to building a diverse workforce and a culture of inclusivity, belonging and equity for all. We believe that our greatest strength draws on the different backgrounds, cultures, perspectives and experiences of our employees.

Westat is seeking a Senior Research Associate to focus on social science mixed methods quantitative and qualitative research projects for the federal government. The candidate should have a content focus in areas such as public health communications, consumer motivations, risk perceptions, decision-making, experimental design, and/or message testing with proven familiarity with social science mixed methods quantitative and qualitative analytic techniques (e.g., ANOVA, ANCOVA, linear and logistic regression, NVivo).

Job Responsibilities

  • Directing the design, execution, and interpretation of research across a variety of quantitative and qualitative methodologies.
  • Leading projects and teams in mixed methods qualitative and quantitative research.
  • Presenting and writing about research findings to a variety of audiences to develop, improve, and evaluate communication materials and programs.
  • Contributing knowledge and expertise in the social sciences (e.g., experimental social psychology, sociology) for various research efforts.
  • Building new relationships with agencies, business partners and universities to support current and future work.
  • Writing and leading technical proposals for government clients.

Basic Qualifications:

  • A PhD in social psychology, sociology, or social science-related field and a minimum of 5 years of experience.
  • Demonstrated experience publishing manuscripts through the peer-review process and/or publishing in peer-review journals.
  • Quantitative and qualitative research experience
  • Focus group moderation experience.
  • Mixed methods evaluation expertise
  • Experience analyzing quantitative data using standard software packages (e.g., SPSS, SAS, or R) and/or qualitative data using NVivo.

Preferred Qualifications:

  • Experience managing federal contracts.
  • Experience writing government proposals.

Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance. Eligible employees may participate in:

  • Employee Stock Ownership Plan
  • 401(k) Retirement Plan
  • Paid Parental Leave
  • Vacation Leave
  • Sick Leave
  • Holiday Leave
  • Professional Development
  • Health Advocate
  • Employee Assistance Program
  • Travel Accident Insurance
  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Short Term Disability Insurance
  • Long Term Disability Insurance
  • Life and AD&D Insurance
  • Critical Illness Insurance
  • Supplemental Life Insurance
  • Flexible Spending Account
  • Health Savings Account

Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity or expression, or any other protected status under applicable law.

To apply, please do so here

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Community Outreach Coordinator

Evolution Research Group 

Title: Community Outreach Coordinator

Location: RBA-Staten Island, NY

Job Description:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 22 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

Do you like to get out into the Community?

Role: Hybrid-onsite 1-2 days/week and then out in the community the rest of the week.

Richmond Behavioral Health is seeking a full-time Community Outreach Coordinator for our clinical research facility located on Staten Island. Community Outreach Coordinator will be responsible for building and maintaining relationships with healthcare providers, social support programs and advocacy to educate and recruit patients for clinical research trials. Applicant must have strong communication skills, work independently, trustworthy, professional, compassionate, comfortable with public speaking, and be willing to work with all demographics within the community. Established connections within the mental health community is helpful.

Responsibilities:

  • Assist the Site in the facilitation of the recruitment process including identifying referral sources, clinical trial participants, and community partnerships.
  • Assist Site in developing and updating timelines for recruitment development projects.
  • Track the progress of these projects to provide metrics and measurement against established benchmarks.
  • Assist Managers with periodic report generation and review.

Skills and Qualifications:

Education and experience

  • Bachelor's degree preferred; 3+ years of experience in pharmaceutical/medical sales, marketing, communications, or outreach activities.
  • Proven organizational ability and strong attention to detail.
  • Familiar with Microsoft Office (MSWord, PowerPoint, Excel, Publisher, Outlook, etc.) project management software and website development

 To apply, please do so here

University Hospitals

In a quest to improve outcomes for our patients through research and scientific innovations, University Hospitals has helped to advance medical science, clinical practice, and patient care around the world. As one of the nation’s leading academic medical centers and community hospital networks, we’ve
expanded across Northeast Ohio to deliver what matters most to our patients - personalized,compassionate care; medical discovery and breakthroughs; and high-quality, affordable care close to home.


University Hospitals Clinical Research Center, the central infrastructure supporting clinical research across the system, has a vision that every patient entering the UH system will be given the opportunity to learn about or participate in a research study.

They have multiple open roles. Go ahead and apply here

Senior Biostatistician

23393BR

Job Description

Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.

Westat is committed to building a diverse workforce and a culture of inclusivity, belonging and equity for all. We believe that our greatest strength draws on the different backgrounds, cultures, perspectives and experiences of our employees.

Westat is seeking a Senior Biostatistician to lead statistical analyses on various types of research projects involving epidemiological, administrative, and clinical datasets. You will collaborate and consult with external investigators and internal project team members on your work designing and executing analyses. You will provide biostatistical support including design and data analysis for Westat projects and contribute to scientific peer reviewed publications. You will present computational and statistical analysis results to collaborators and assist them with data access, analysis, and interpretation of results. You will build or internalize appropriate algorithms and techniques to answer defined epidemiologic questions, ensuring that results are scientifically robust and well documented.
 
This role is remote eligible.
 
Responsibilities:

  • Collaborate with external investigators in developing study aims and research hypotheses.
  • Provide study design advice to investigators including assessment of appropriateness and feasibility.
  • Estimate optimal sample size for the desired power, recognizing resource limitations of individual research studies.
  • Develop statistical considerations and analysis methods for study protocols.
  • Develop statistical analysis plans for research projects including guiding the data management team in terms of database design, selection of statistical methods, creation of project timelines, and development of formats for presenting results.
  • Oversee, lead, and consult on all phases of analytical programming, data management, macros, quality control and reporting of research data.
  • Conduct statistical analysis for epidemiological, clinical and evaluation projects including implementation and refinement of statistical methods, preparation of formatted tables of results and other outputs, verification of the accuracy of results, and assumption of primary responsibility for the analysis and presentation of project data.
  • Lead efforts in researching, recommending, and implementing methods to validate, troubleshoot, and interpret results.
  • Participate in quality control and quality assurance processes and review code output, tables, and charts.
  • Present analytical results orally and in writing to internal and external audiences, incorporating descriptions of methods, relevant literature, and other background material to provide context for the results.
  • Serve as a data resource for research project teams and interact directly with clients and external investigators.

Basic Qualifications:

  • Typically requires a PhD in Biostatistics, Statistics, Bioinformatics, Epidemiology or a related field of study and 2-4 years of experience; or an equivalent combination of education and experience.
  • Experience in health research, advanced data analysis, and experience in analyzing research data using statistical packages.
  • Experience with SAS, R and other statistical packages.

Preferred Qualifications:

  • Experience organizing and manipulating large data sets (e.g., EHR, claims, omics and other datasets).
  • Skill and expertise in a broad range of statistical methods and approaches including analysis of longitudinal and repeated measures data, methods for handling missing data, use of linear and non-linear models, use of published non-parametric and parametric statistical methods, survival data analysis methods, logistic regressions.

 
In this role, you’ll use your well-developed communication and critical thinking skills to express complex statistical concepts and technical information clearly to audiences with and without formal statistical training. You’ll also be adept at independently performing analysis, programming, implementation and testing of data; and comfortable with accountability, meeting tight deadlines and completing complex work assignments.

Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance. Eligible employees may participate in:

  • Employee Stock Ownership Plan
  • 401(k) Retirement Plan
  • Paid Parental Leave
  • Vacation Leave
  • Sick Leave
  • Holiday Leave
  • Professional Development
  • Health Advocate
  • Employee Assistance Program
  • Travel Accident Insurance
  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Short Term Disability Insurance
  • Long Term Disability Insurance
  • Life and AD&D Insurance
  • Critical Illness Insurance
  • Supplemental Life Insurance
  • Flexible Spending Account
  • Health Savings Account

 

Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity or expression, or any other protected status under applicable law.

Career Area

Research - Health Studies

Pay Range

90-125k

Bonus Eligibility

Yes

To apply, please click here

Clinical Research Specialist - Site Solutions

Veeva [NYSE: VEEV] is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, our customers range from the world’s largest pharmaceutical companies to emerging biotechs. Veeva’s software helps our customers bring medicines and therapies to patients faster.
We are the first public company to become a Public Benefit Corporation. As a PBC, we are committed to making the industries we serve more productive, and we are committed to creating high-quality employment opportunities.
Veeva is a Work Anywhere company which means that you can choose to work in the environment that works best for you - on any given day. Whether you choose to work remotely from home or work in an office - it’s up to you.
The Role
The Clinical Research Specialist - Site Solutions will be responsible for increasing the adoption and expansion of SiteVault. The CSM will provide consultation to customers that are strategic, data-driven, relationship-oriented, and technical while also contributing to the overall Site Solutions team at Veeva. 

What You'll Do

      • Strategic Consultation
      • Partner with research sites to make them committed advocates of SiteVault and active, engaged customers
      • Support sites with low expansion and/or adoption by highlighting and increasing the value that SiteVault provides their organization
      • Support the long-term success of more complex sites as they work to implement SiteVault across multiple areas within their organization
      • Data-Driven Consultation
      • Onboard new SiteVault customers
      • Identify key SiteVault metrics to track successful usage over time for various research site types (often with unique needs)
      • Develop and implement adoption and expansion plans for sites in order to proactively ensure and measure their continued success with SiteVault
      • Relationship-Oriented Consultation
      • Earn the trust and respect of research sites in order to promote transparent communication and gain a clear understanding of their challenges and goals
      • Build relationships with low-adopting SiteVault sites and work to provide them with more value
      • Schedule routine check-ins to support a successful transition for key SiteVault to SiteVault Enterprise customers when appropriate
      • Support the success of SiteVault user communities
      • Technical Consultation
      • Possess a strong technical understanding of SiteVault
      • Understand and articulate the benefits of available configurations in SiteVault Enterprise
      • Connect the specific challenges research sites face with clear solutions in SiteVault through product demonstrations whenever possible
      • Stay abreast of evolving features in SiteVault and identify their value to customers overall as well as to individual customers
    • Dedicated Team-Player
    • Support and communicate with the sales team regarding potential Enterprise customers
    • Provide insight to the product team on behalf of SiteVault customers
    • Support marketing with messaging and engagement for research sites
    • Work closely with training and support to ensure SiteVault customers’ needs are met

Requirements

    • See technology as playing a pivotal role in solving the many challenges research sites face today
    • Experience working at a clinical research site in the US
    • Understand and have awareness of clinical research regulatory processes at research sites
    • Possess strong communication, public speaking, organizational, interpersonal, critical thinking, and problem-solving skills

Nice to Have

    • Experience with using, implementing, and/or managing an electronic regulatory system at a clinical research site
    • Experience with using, implementing, and/or managing a clinical trial management system at a clinical research site
    • Experience with tracking operational data to drive decision-making, inform processes and identify priorities 
    • Experience managing clinical research teams
    • Experience as a user across a broad range of clinical research technology applications
#LI-Remote
#BI-Remote
To apply, please to click here
Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.
Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com.

Senior Project Manager - Clinical Data Management (Remote)

Veeva [NYSE: VEEV] is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, our customers range from the world’s largest pharmaceutical companies to emerging biotechs. Veeva’s software helps our customers bring medicines and therapies to patients faster.

We are the first public company to become a Public Benefit Corporation. As a PBC, we are committed to making the industries we serve more productive, and we are committed to creating high-quality employment opportunities.

Veeva is a Work Anywhere company which means that you can choose to work in the environment that works best for you - on any given day. Whether you choose to work remotely from home or work in an office - it’s up to you.

The Role

Veeva’s Vault CDMS platform will truly change how the industry runs clinical trials and we want you on our team! Veeva Systems is looking for a Biometrics Project Manager who has deep customer focus and a passion for helping customers transform the way they manage their clinical trial processes, data, and content within our CDB product. Veeva CDB is a clinical data platform that aggregates and harmonizes all data sources to provide our customers with clean, well-organized data that is ready-to-use faster. Gone are the days of complex integrations that limit clinical data availability, now research teams can make faster and more informed decisions.

This is an expert-level role that requires strong Biometrics experience, customer-focused project management, and problem-solving skills as you lead and manage large-scale global enterprise cloud software projects for Veeva CDB. You are able to drive governance at all levels and lead a consulting team in an enterprise implementation project and thrive in a start-up environment with professional agility.

If you excel in building productive relationships, aligning strategies, creating communities, and excelling in a technical, fast-paced environment then this could be an excellent match for you.

This is a remote, full-time permanent role with Veeva. This is a customer-facing role and we have no work location requirement if you are in close proximity to an airport and able to meet future travel requirements.

Veeva Systems does not anticipate providing sponsorship for employment visa status (e.g., H-1B, OPT) for this employment position.


What You'll Do

  • Collaborate with CDB leadership and CDMS Project Managers to establish and execute project management methodology for delivering CDB Services
  • Provide oversight for CDB Services projects and studies to deliver contracted services on time and with high customer satisfaction
  • Establish close, collaborative relationships with customer stakeholders to understand and act on CDB customer needs
  • Drive governance and demonstrate leadership by working across customer and internal teams to support all phases and workstreams within the implementation of Vault CDB
  • Manage day-to-day project activities and project administration. Enable your team to focus on solution design, prototyping, configuration, training, and documentation
  • Mentor project team members in the CDB Services organization and identify growth opportunities
  • Proactively manage risk, anticipate potential problems, and identify mitigation strategies. Be transparent in all communications and reflective in conducting post-project assessments — identify learnings that will help improve the overall process
  • Establish and provide regular reporting on project status, key metrics, and deliverables and customize to address key stakeholder groups

Requirements

  • 7+ years of direct experience leading teams working with EDC/CDMS clinical software solutions in data management, and/or delivering project management for Biometrics services in a CRO or Sponsor organization
  • Experience in reporting to senior/executive level stakeholders and technology teams with superior communication skills
  • Exceptional project management skills with the ability to prioritize and manage multiple projects in a cross-functional environment that values speed
  • Position requires a level of confidence to hold the line with customers and internal teams and be an advocate for the project
  • Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and quality results
  • Ability to travel up to 30%
  • #LI-Remote
  • #BI-Remote

To apply for this role, please click here



Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world.

Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com.

 

Multiple Full Time Clinical Research Coordinator Opportunity – in Poughkeepsie, NY & Danbury, CT 


Nuvance Health has multiple exciting opportunity for an experienced clinical research coordinators working in Poughkeepsie, New York and Danbury, Connecticut locations. The clinical research coordinator will be responsible for coordinating clinical research activities within the research division through the use of Good Clinical Practice Guidelines.

This position follows a Monday-Friday office schedule of 8:30am-5:00pm. We offer a highly competitive benefits package including health, dental, vision, life insurance, disability, generous paid time off, and matching 401K. 


Essential Responsibilities:

  •  Function independently in clinical research setting and responsible for the complete coordination of assigned clinical research protocols from national research agencies and pharmaceutical corporations.
  • Assists investigators, research and, medical center staff with the initiation of research protocols.
  • Ensures accurate and timely communication is facilitated, presenting the research division in a positive manner.
  • Supports the management of clinical research databases to ensure records are accurately and timely maintained.
  • Demonstrates regard for the dignity and respect of medical center personnel and community residents as defined in the philosophy of HVCVP or Vassar Brothers Medical Center.
  • Blood draws/phlebotomy, EKG’s, body measurements.
  • Maintain and Model REACH Values (Respect, Excellence, Accountability, Compassion,Honor).
  • Demonstrates regular, reliable and predictable attendance.
  • Performs other duties as required.

Requirements:

  • Bachelor’s Degree, Allied health professional degree, or equivalent experience
  • Minimum of one-two (1-2) years’ experience with EDC and CRFs.


Minimum Knowledge, Skills and Abilities Requirements: 

  •  Ability to multi-task and work as a team and independently.
  • Knowledge of Medical Terminology, good clinical practice, FDA, OHRP, and HIPAA policies. 
  • Outstanding interpersonal communication skills.
  • Strong attention to detail, self-motivation, and good organizational skills.
  • Ability to prioritize quickly and follow directions and protocol.
  • License, Registration, or Certification Requirements:
  • Basic Life Support (BLS) certified or willing to obtain upon employment. Valid driver’s license and reliable transportation. PREFER: Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or certified within 2 years.

Environmental Factors:

Bio-hazardous Waste Chemicals/Commercial Products Exposure to Latex Interacting with a Diverse population Patient Care/Handling Duties Risk of Electrical Shock


Physical & Mental Requirements:

  • Repetitive Motion
  • Noise Level – Varies from Quiet to Very Loud
  • Fumes or Airborne Particles
  • Experiencing challenging conditions where a professional attitude will be required
  • Blood Borne Pathogens. Job may require performance or tasks that involve potential for exposure to blood, body fluids, or tissues.


About Nuvance Health:
Nuvance Health serves 1.5 million residents across New York and Connecticut and includesmore than 2,600 aligned physicians, 12,000 employees, seven hospitals (Danbury Hospital, NewMilford Hospital, Northern Dutchess Hospital, Norwalk Hospital, Putnam Hospital Center,Sharon Hospital, and Vassar Brothers Medical Center), a large network of primary care and specialty practices, and multiple affiliated organizations. We are a Section 501(c)(3) tax-exempt organization and therefore eligible employees mayqualify for forgiveness of certain federal student loans under the Public Service LoanForgiveness Program.


WE ARE AN EQUAL OPPORTUNITY EMPLOYER. Qualified Applicants are considered forpositions and are evaluated without regard to mental or physical disability, race, color, religion,gender, national origin, age, genetic information, military or veteran status, sexual orientation,marital status or any other classification protected under applicable Federal, State or Local law.

For more information or to apply for this position, please contact Stephanie Ramirez,Recruiter, via email: stephanie.ramirez @nuvancehealth.org

Clinical Research Coordinators- Clinical Trials

Nuvance Health has multiple exciting opportunity for an experienced clinical research coordinators working in Poughkeepsie, New York and Danbury, Connecticut locations.

The Clinical Research Coordinators collaborates with departmental leadership and research staff in the coordination of all aspects of clinical research studies. Responsibilities include; patient screening and recruitment, coordination of care of the research patient, protocol implementation, data collection and query resolution, and submission to the Institutional Review Board (IRB). Coordinates studies in varied therapeutic areas including but not limited to Cardiovascular, Pulmonary, Gastroenterology, Neurology, Endocrinology, Dermatology and Rheumatology. Functions independently in a clinical research setting and responsible for the complete coordination of assigned clinical research protocols from national research agencies and pharmaceutical corporations.

This position follows a Monday-Friday office schedule of 8:30am-5:00pm. We offer a highly competitive benefits package including health, dental, vision, life insurance, disability, generous paid time off, and matching 401K. 

  1. Screens patients for study participation e.g. reviews medical record, collaborates with medical & research staff, etc. and procures informed consent.
  2. Maintains accurate and thorough documentation on all source documents and case report forms (CRFs) for each study patient. Resolves all patient queries.
  3. Maintains communication with investigators/researchers, patients, internal and external collaborators (e.g. consulting physicians), sponsors, federal regulatory agencies, and other involved parties as required.
  4. Participates in investigator, coordinator, or study initiation meetings accordingly. Coordinates and participates in monitoring visits/audits with regulatory agencies or sponsors.
  5. Maintains current regulatory (GCP, HSR) and study specific required trainings.
  6. Prepares and submits all study protocols, consent forms, and other required documents to the Institutional Review Board (IRB).
  7. Educates hospital staff about protocols through in-services, written materials and one-on-one interaction, for each study and each patient, and for general marketing.
  8. Demonstrates flexibility in daily routine and effectively accommodates for the needs of the job (e.g. early or late patient enrollment).
  9. Performs procedures including EKG, Phlebotomy, blood and body fluid sampling, packing and shipment of human samples, body measurements and examinations within scope of practice and training, consistent with clinic and study specific policies/procedures and scope of care under the guidance of the supervisor.
  10. Fulfills all compliance responsibilities related to the position.
  11. Maintain and Model Nuvance Health Values.
  12. Demonstrates regular, reliable and predictable attendance.
  13. Performs other duties as required.

Education and Experience Requirements:
• Bachelor Degree OR
• Allied Health Professional Degree AND three years job-related experience.
• Minimum 1-year clinical experience in medical field.
• PREFER: Clinical Research experience

License, Registration, or Certification Requirements:

  • Basic Life Support current or willing to take course
    • Valid Driver’s license
    • PREFER: Professional research certification
    • PREFER: Basic Life Support

About Nuvance Health:

Nuvance Health serves 1.5 million residents across New York and Connecticut and includes more than 2,600 aligned physicians, 12,000 employees, seven hospitals (Danbury Hospital, New Milford Hospital, Northern Dutchess Hospital, Norwalk Hospital, Putnam Hospital Center, Sharon Hospital, and Vassar Brothers Medical Center), a large network of primary care and specialty practices, and multiple affiliated organizations.

For more information or to apply for this position, please contact Stephanie Ramirez, Recruiter, via email stephanie.ramirez@nuvancehealth.org

We are a Section 501(c)(3) tax-exempt organization and therefore eligible employees may qualify for forgiveness of certain federal student loans under the Public Service Loan Forgiveness Program.

WE ARE AN EQUAL OPPORTUNITY EMPLOYER. Qualified Applicants are considered for positions and are evaluated without regard to mental or physical disability, race, color, religion, gender, national origin, age, genetic information, military or veteran status, sexual orientation, marital status or any other classification protected under applicable Federal, State or Local law.

Headlands Research

At Headlands Research, we are building the best clinical trial company in the world. We’re an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding participant outreach and participation. Founded in 2018, our company is in high growth mode; we operate 15 clinical trial sites in the US and Canada and have rapid expansion plans.

This Clinical Research Coordinator role will be based in Southfield, MI.
You can read more about us at headlandsresearch.com.

Headlands Research is looking for a Clinical Research Coordinator to manage clinical research protocols. This individual will work directly with the investigators, and other research staff to ensure protocol visits are being conducted according to ICH GCP guidelines.

The ideal candidate:

  • Clinical Research Certification Preferred
  • Other Medical licensure/certifications (Medical Assistant, etc.)
  • Previous research experience preferred

  Duties

  • Comprehend study design of each protocol that is assigned
  • Perform procedures in compliance with the study protocol
  • Recruit and screen study subjects according to specific protocol requirements
  • Collect and record study data in source documents via electronic system (CRIO)
  • Manage study related activities
  • Adherence to protocol requirements
  • Review laboratory data
  • Assess and document compliance
  • Manage investigational product
  • Assess, record, and report Adverse Events as outlined in the protocol
  • Manage/train ancillary staff

Requirements Qualifications
Education:

  • Experience and training in conducting clinical trials with knowledge of ICH GCP OR Two years of college in a health-related program or LPN OR
  • Bachelor’s degree in a health or scientific related program
  • A thorough understanding of regulatory requirements
  • Excellent interpersonal and communication skills: Able to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources.
  • Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens
  • Experience with CRIO (Clinical Trial Management System) is a plus
  • Experience with administering vaccines is a plus

To apply, please do so here

Clinical Sciences & Study Management (CSSM) is building the world’s best Research and development team for new medicines—and you can help make us even better.


Responsibilities:

  • Responsible and accountable for the oversight and leadership of clinical program execution. 
  • Leads and directs teams in key program planning and resourcing, development and execution elements (e.g. program level overviews, issue escalation/mitigations,
  • presentations at Sr. Management meetings, program level cross functional meetings and governance, advisory meeting preparation). 
  • Has overarching responsibilities and/or oversight of multiple clinical programs or disease areas or highly complex programs.
  • Assists the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations, due diligence activities, etc. 
  • Provides input into strategic direction for program level and/or therapeutic aligned end-to-end activities (planning through post-approval). 
  • Ensures consistency across program elements. Facilitates and collaborates with internal and external stakeholders in support of clinical program objectives. 
  • Builds talent and capabilities of team members through proactive coaching, mentoring and development opportunities.
  • May include management of direct reports including assignment of resources, professional development, and performance management.


Minimum required education:

  • Degree in the Life Sciences or significant experience in clinical development (>18 years)
  • Bachelor’s degree with 15+ years’; or MS with 12+ years’; or PhD with 6+ years’ relevant career experience.
  • Required experience and skills:
  • Pharmaceutical and/or clinical drug development experience.
  • Excellent oral (including presentation) and written communication, project management, and computer/database management skills.


Preferred experience and skills:

  • Clinical trial experience within the last 5 years in any of the following disease areas is preferred: gastrointestinal (e.g., ulcerative colitis, Crohn’s disease, etc.), rheumatoid (e.g., lupus, inflammatory myopathies, etc.) or dermatologic (e.g., atopic dermatitis, vitiligo, etc.).
  • We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world.
  • We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

To apply, please do so here.

 

Supervisor, Clinical Research Data Team- Winship Cancer Institute Req# 93376

JOB DESCRIPTION:

  • The Supervisor, Clinical Research Data Team (SCRDT) supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University.
  • The SCRDT is responsible for overseeing the data activity of complex research trials.
  • This role collaborates with the clinical and regulatory teams to document and report study patient enrollment, treatment, and follow-up information into databases as specified by research protocols.
  • This position is responsible for the implementation and conduct of data management and compliance of multiple research projects and interacts closely with institutional investigators, study sponsors, and the study team.
  • The SCRDT is responsible for providing guidance and supporting training of DC I and DC II positions.
  • The SCRDT serves as a resource regarding clinical research and compliance for Investigators, Nurses, Pharmacists, Pathologists, Radiologists, and other Healthcare personnel involved in the care and management of patients at WCI.

WORK PERFORMED:

  • Provide supervision and day-to-day oversight to the Data Coordinators Is and IIs
  • Develop database clinical trial data specification and metrics, to decrease data delinquencies, missing documents, data accuracy query logic and data validation
  • Responsible for double-data entry (DDE) and quality management of data entry for NCTN, IIT and sponsor clinical trials
  • Create and maintain project Data Management documentations (Data Management Plan)
  • Extract and monitor clinical trial data to identify issues or trends reporting this information to Winship CTO Leadership
  • Ensure clinical trials data within EDC, OnCore, EPIC, and sponsor CTMS is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and final database lock ¿ included but not limited to data reconciliation
  • Manage data inspections and/or audits with clinical trials monitors, FDA inspectors, NCTN auditors, quality management, data safety and monitoring committee and Emory CTAC
  • Ensures data system compliance by following the established guidelines of national regulatory authorities
  • Independently responsible for all aspects of clinical data management including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
  • Reviews and analyzes information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols including but not limited to industry, cooperative group, and investigator-initiated studies.
  • Attends study team meetings and provides updates to study team members regarding protocol data management activities, including data entry timelines, database locks, unique study requirements, and query management. Also provides support, ongoing education and updates to study team members, physicians, nurses, and other healthcare professionals regarding data-related protocol activities.
  • Provides onboarding, training, and quality assurance of CRDC I and II positions
  • Attends protocol related training meetings and completes all required study training
  • Liaises with sponsors and the in-house monitoring team, schedules monitoring visits, and addresses monitoring report findings.
  •  Leads the CRDC effort in preparing for and participating in quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate.
  • Establishes and maintains procedures and systems (i.e., computerized database) for research coordination and data management. Provides support to Winship¿s Informatics team as they develop and improve research information systems
  • Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations and department policies. Maintains controls to assure accuracy, completeness, and confidentiality of research data.
  • Maintains confidentiality standards for all potential and enrolled patients; complies with federal Health Insurance
  • Orders and maintains equipment and supplies for research protocols and supports DC I and II as needed.
  • Performs other duties as assigned.

MINIMUM QUALIFICATIONS:

  • Bachelor's in a scientific, health related, or business administration program and three (3) years of clinical research data management experience or an equivalent combination of education and experience.
  • Experience in electronic data capture (EDC) systems and clinical trials monitoring systems (CTMS) required.

PREFERRED QUALIFICATIONS:

  • Working knowledge of ICH/GCP guidelines, clinical research, clinical trials process and FDA regulations preferred. ACRP/SoCRA (or equivalent) certification preferred within three (3) years of hire Position intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher.
  • Certification/license

To apply, please do so here

Clinical Research Nurse II- Winship Cancer Institute Req# 99987

JOB DESCRIPTION:

  • Coordinates implements and evaluates clinical research trials, studies and projects.
  • Provides direction in the development of research protocols.
  • Recruits and screens potential study participants, and develops and conducts patient and family education accordingly.
  • Oversees financial accounts to ensure operations remain within approved levels.
  • Performs patient evaluations, administers medications and research instruments and provides nursing support to perform specialized diagnostic, therapeutic and surgical procedures.
  • Makes referrals to in-house or community professionals and serves as clinical resource.
  • Collects data, assists in developing data collection systems and compiles reports.
  • May provide infusion duties.
  • Assists in writing research grants, publications in medical and nursing literature, study materials, brochures and correspondence.
  • Provides direction and may supervise other Research Nurses or other support members.
  • Performs related responsibilities as required.
  • Employees in this classification may be required to work with, take specific precautions against and/or be immunized against potentially hazardous agents.

MINIMUM QUALIFICATIONS:

  • Licensed as a Registered Nurse in the state of Georgia and three years of related nursing experience.
  • Must be credentialed through Emory Healthcare under the category of RN II.

NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

To apply, please do so here

Assistant Director, Clinical Research Staff- Winship Cancer Institute Req# 94786

JOB DESCRIPTION:

  • Provides direct supervision of staff; prepares operational reports and assists in providing Winship specific education and training.
  • Responsible for direct oversight and supervision of Clinical Research Nurses, Clinical Research Associates, Research Interviewer, and Data Coordinators (Clinical Research Staff).
  • Hires, trains, and evaluates staff.
  • Tracks and assures timely management of staff effort reporting for financial management.
  • Assists the director in the understanding and applying the business model as needed.
  • Supports and assists in research coordination as needed. Reviews site monitoring visits and responds to all exit reviews.
  • Develops, implements and maintains SOPs to ensure timely reporting of adverse events, serious adverse events and unanticipated problems to the Winship Data Safety Monitoring Committee.
  • Monitors the timeliness of response to all sponsors request for queries by working groups.
  • Develops strategies to maximize timely completion of CRF's within the program.
  • Incorporates the use of ONCORE in daily operations.
  • Integrates processes to ensure subject data in Oncore and ERMS are updated in a timely manner.
  • Holds staff accountable for timely and accurate data updates.
  • Provides education to the Winship community and Emory personnel in all aspects of clinical trials.
  • Helps develop Winship specific minimum learning standards/requirements for Clinical Coordinators and physician-investigators, and maintains appropriate training records for participants.
  • Works with clinical staff in developing and implementing patient education resources for clinical trials.
  • Develops an integrated, Winship specific orientation program, and maintains appropriate training records for participants.
  • Collaborates with Emory Healthcare Nursing and Office of Quality in developing protocol specific materials for the orientation and education of clinical staff in the conduct of clinical research protocols.
  • Demonstrates knowledge of and competency in all regulatory requirements (FDA, GCP, ICH).
  • Responsible for regulatory compliance at all levels.
  • Performs other responsibilities as required.

MINIMUM QUALIFICATIONS:

  • Master's degree in a health related discipline or Business Administration and five years of progressively responsible research, nursing, clinical trials or related experience which includes supervisory responsibility
  • OR an equivalent combination of education, training and experience.

PREFERRED QUALIFICATION:

  • SOCRA/ACRP or related research certification

NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

 To apply, please do so here

Clinical Trials Manager- Winship Cancer Institute Req# 77307

JOB DESCRIPTION:

  • Typically supervises a staff of 2-5 employees.
  • Trains new clinical trials staff.
  • Tracks enrollment, sponsor payments, and salary.
  • Provides leadership in business development.
  • Assists residents in preparing research projects by facilitating IRB submissions and protocol writing.
  • Responsible for preparing NIH proposals and routing through the system.
  • Assists in creating and maintaining Standard Operating Procedures.
  • Performs related responsibilities as required.

MINIMUM QUALIFICATIONS:

  • A bachelor's degree in a related field and eight (8) years experience in clinical trials, two of which are in the clinical area.
  • A master's degree and four years of experience in clinical trials, one of which is in the clinical area will be considered equivalent.

NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

 To apply, please do so here

Senior Administrator, Data Safety and Monitoring Committee (HYBRID)- Winship Cancer Institute Req# 83292

JOB DESCRIPTION:

  • The Senior Administrator, Data Safety and Monitoring Committee (DSMC) at Winship supports and coordinates the Data Safety and Monitoring Committees (DSMC) in following the Winship Data Safety and Monitoring Plan (DSMP).
  • Responsible for providing quality data in order to respond to the DSMP requirements.
  • Provides overall support and organization for all committee functions and responsibilities.
  • Serves as a point of contact activities related to monitoring adherence to DSMP and policies and procedures adopted by Winship Cancer Institute as required by the Cancer Center Support Grant Guidelines (CCSG).
  • The Senior Administrator, DSMC is responsible for: 1) the preparation of the agenda and review of materials prior to the committee meeting to assure that material required for review are available in accordance with the DSMP; and 2) fulfilling the role of liaison to Committee Chairmen, Program Leaders, Principal Investigators, Regulatory Specialists, and Study Coordinators.
  • Responsibilities include the following duties: Process, review, and assess SAE, device incident, and pregnancy reports from clients' ongoing drug or device clinical trials in a timely manner.
  • Responsible for the maintenance, revision and oversight for the Data Safety and Monitoring Plan (DSMP).
  • Tracking and evaluating monitoring trends for IITs and reporting the trends to Winship CTO Leadership.
  • Partnering with Training/Education to ensure monitoring trends are addressed within the clinical trials teams and regulatory and training/competency materials are revised to meet compliance standards.
  • Ensure compliance with all applicable regulations and timelines for safety case processing and reporting.
  • Responsible for thorough assessment of required data entry elements and timely accurate input of that data into the Clinical Trials Management System (CTMS) to facilitate efficient project management.
  • This responsibility commences at the original point of project entry, continues through original IRB approval and Activation of the project, and is sustained through periodic monitoring of accuracy and clarity of data elements. 
  • Independently verifies submitted protocols meet requirements for placement on committee agenda by reviewing submitted form, protocol priority diagrams, and protocols prior to assignment. 
  • Coordinates and attends Data Safety and Monitoring Committee meetings in accordance with Cancer Center Support Grant guidelines to ensure the success of the Cancer Center's protocol review and monitoring process.
  • Responsible for compiling agendas, assigning committee reviewers, composing official minutes, and constructing reports and correspondence in final form for Winship review committees, all of which are components essential to the success of the Core Grant.
  • Prepares DSMC documents in collaboration with the study PI, including confidentiality agreements, conflict of interest statements and charters for each study requiring DSMC review.
  • Disseminates policy decisions and resolutions to Winship study teams from the Data Safety and Monitoring Committees.
  • Takes on special projects or tasks as required and needed.
  • Ensures orientation and training policies for investigators comply with local and federal regulations and accreditation standards.
  • Seek out new practice methods and principles, applying them to existing clinical research practices.  Assists the program and offices in complying with all accreditations, legal, regulatory, and safety requirements.
  • Uses group participation skills when working as a member of a committee or informal work group. Participates actively and positively on assigned committees.
  • Accurately identifies opportunities for improvement. 
  • Actively demonstrate facilitative leadership to foster productive teamwork through coaching, mentoring, and counseling.
  • Other duties as assigned.

The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.

 

MINIMUM REQUIREMENTS:

  • Bachelor’s degree in a related field (scientific or health related) and seven years experience in clinical trials management, sponsored research, or regulatory management, including five years trial or related monitoring experience OR an equivalent combination of education and experience.
  • Certification by Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ASCP) is required within three (3) years of hire.

PREFERRED REQUIREMENTS:

  • Previous supervisory experience.
  • Strong verbal and written communication skills with the ability to understand and summarize medical terminology.
  • Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
  • Experience with good clinical practices and clinical trials development or implementation.
  • Familiarity with Clinical Trials Monitoring Systems (CTMS). Experience as a clinical manager, operations manager, or general manager.
  • Experience in Phase I through Phase IV clinical trials with knowledge of drug/medical device safety regulations and industry standards.
  • Experience in indirect management of team members, including assisting in the development, training, and assignment of work/projects to other team members.

NOTE: Position tasks are generally required to be performed in-person at an Emory University location.  Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

To apply, please do so here

Frederick National Laboratory

Clinical Research Budget Manager

Job ID: req2978
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

 

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRPD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

KEY ROLES/RESPONSIBILITIES

  • Provides primary oversight of financial operations and staff across all institutes supported by CMRPD
  • Hires, trains, mentors, and manages multiple levels of financial management staff
  • Establishes and monitors team goals and performance
  • Develops and maintains financial operations processes and procedures
  • Communicates with the Director, senior management, internal CMRPD program staff, and government project officials
  • Collaborates with Leidos Biomed Financial Planning & Analysis group on Contract deliverables
  • Prepares annual project budgets and project identification numbers
  • Maintains annual budget assumption documents with up-to-date information to track for actuals, approvals, and estimates at completion details
  • Performs technical analysis to determine present and future financial performance
  • Maintains and tracks budget documentation and conducts regular audits to ensure the accuracy and completeness of these records
  • Maintains staffing reports by project, by person, and by position
  • Prepares, monitors, and analyzes cost proposals including budget development and business volume preparation
  • Works with the primary program managers and clinical research teams to develop internal budgets that include all projected costs applicable to the clinical research studies and projects based on study protocol and related documents
  • Use of Time-To-Task model for budget development
  • Prepares various project and directorate level financial reports including labor analyses, annual and multi-year projections, and estimates at completion
  • Analyzes multiple funding sources for determination of proper cost allocation
  • Gathers, analyzes, prepares, and summarizes recommendations for financial plans, acquisition activity, trended future requirements, operating forecasts, etc.
  • Prepares financial forecasting and reconciliation of internal accounts
  • Organizes and implements a variety of responsibilities related to the flow of materials, products, services, and associated systems information
  • Reviews and approves purchase requisitions, blanket orders, and credit card purchases
  • Reviews and approves credit card statements
  • Reviews and approves costs related to new/proposed contracts, modifications/amendments, and invoices for financial verification
  • Leads financial meetings with government customers
  • Tracking of team deliverables and action items to ensure completion
  • Contributes to development of annual report narrative

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of a Bachelor’s degree from an accredited college or university (according to CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the educational requirements, a minimum of eight (8) years progressively responsible job-related experience
  • Progressively responsible experience must demonstrate increased independence and overall responsibility for more complex projects at a program/directorate level
  • Experience managing financial staff at various levels
  • Experience writing proposal business volumes
  • Demonstrated experience with analysis of budgets and costs, including burn rates and cost projections
  • Demonstrated financial management knowledge and experience in the biotech, pharmaceutical, or clinical research industry
  • Demonstrated ability of budgeting and cost tracking
  • Ability to collect and disseminate information in a clear, concise manner
  • Ability to create Excel and database reports
  • Ability to track multiple projects concurrently
  • Strong working knowledge of MS Office Suite including Excel (advanced), PowerPoint (intermediate), and Word (intermediate)
  • Excellent research and investigative/financial auditing skills with a high degree of accuracy and attention to detail
  • Demonstrated budgetary and strategic planning experience and responsibilities as it relates to clinical research
  • Ability to review complex documents independently and/or in collaboration with clinical research managers, and determine sufficiency of financial documentation
  • Knowledge of study design, clinical and biospecimen terms used in research studies and scientific and medical concepts and terminology
  • Must be able to obtain and maintain a security clearance
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:  

  • Knowledge of governmental regulations including Federal Travel Regulations and Federal Acquisition Regulations
  • Experience working in a federal contracting environment
  • Familiarity with severable and non-severable funding mechanisms
  • Knowledge of human subjects protection and/or clinical research activities
  • Experience in developing budgets for locations outside of the United States

To apply, please do so here

Frederick National Laboratory

Clinical Research Associate II - REMOTE

Job ID: req2939
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Frederick: INDUS
Location: 5705 Industry Lane, Frederick, MD 21704 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

 

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRPD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides regulatory, clinical trials management, pharmacovigilance, protocol development/navigation and program management support to the Regulatory Compliance and Human Subjects Protection Program (RCHSPP), Office of Clinical Research Policy and Regulatory Operations (OCRPRO) of the National Institute of Allergy and Infectious Diseases’ (NIAID) Division of Clinical Research (DCR).

KEY ROLES/RESPONSIBILITIES

  • Provides clinical trials monitoring for Phase I-III single site and large networks of clinical sites participating in
  • Investigational New Drug (IND) and non-IND protocols
  • Ensures sites are following U.S. Food and Drug Administration (FDA) regulations for INDs, Investigational Device Exemptions (IDEs), International Conference on Harmonisation (ICH)/ Good Clinical Practice (GCP) guidelines, and other applicable regulations
  • Verifies source documentation for the appropriate recording and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs)
  • Critically evaluates clinical data for accuracy and completeness while ensuring the safety and confidentiality of participants according to the study monitoring plans
  • Conducts monitoring of pharmacy records, including receipt, storage, labeling and final packaging, inventory, distribution, accountability and the processing and disposal of returned investigational agents according to the study monitoring plans, protocol and Standard Operating Procedures (SOPs) , chain of accountability
  • Maintains relationships with Investigators, study site staff, network entities, Clinical Research Organizations (CROs) and other CRAs
  • Provides assistance to the clinical investigators and teams to reinforce and enhance a GCP culture
  • Reviews protocol and Informed Consent Forms (ICFs)
  • Coordinates monitoring activities of clinical studies for domestic and international sites including conducting on site or remote site initiation, monitoring and close-out visits, completing reports in a timely manner, ensuring the conduct of the trial is in compliance with the approved protocol, SOPs, International Conference on Harmonization/Good Clinical
  • Practices (ICH/GCPs), Institutional Review Board (IRB)s and NIH policies, and applicable regulatory requirements
  • Assists other CRAs and Project Managers in the development of team processes and study-related documents
  • Assists with ensuring required approvals are in place to initiate intramural research
  • Assists in the preparation and production of documents for FDA submissions, as well as IND annual protocol reports and manuscripts
  • Reviews or helps create internal and/or external SOPs, guidelines and tools
  • Travels to domestic and possible international clinical sites as assigned
  • Maintains Essential Documentation File contents and reconciliation of the documentation including ensuring all required essential study documents are current, complete, and accurate
  • Ensures Clinical Trial Database Systems are updated to be current, accurate and complete in a timely manner
  • This position is in- Frederick, Maryland with the ability to work remotely

**THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL** 

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: 

  • Possession of Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the education requirement, a minimum of two (2) years of progressively responsible relevant experience  
  • Ability to work in a clinical research setting, both independently and within a team
  • Ability to prioritize multiple tasks/projects and accomplish goals in expected timelines
  • Ability to communicate effectively, verbally and in writing, with non-technical and technical staff
  • General knowledge of clinical trial fieldwork, monitoring concepts and practices, FDA regulations and GCPs
    Knowledge of TrackWise® or other Clinical Trials Management Systems (or other similar systems (OpenClinica, ClinPlus, etc.)
  • Extensive experience using various software applications such as MS Excel, Word, PowerPoint, and Adobe Acrobat; relational databases structures and reporting software
  • Ability to manage projects involving large volumes of data
  • Must be willing to travel approximately 30-40 % (including to NIH)
  • Previous clinical monitoring and site management experience
  • Ability to obtain and maintain a security clearance 

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:  

  • Infectious diseases experience
  • Knowledge of Department of Health and Human Service (DHHS) regulation and conducting federally funded studies
  • Experience with the development of manual of operations and study monitoring plans
  • Ability to read French or Spanish
  • ACRP Certified CRA or SOCRA Certified Clinical Research Professional
  • Knowledge of international regulatory requirements 

 To apply, please do so here

Frederick National Laboratory

Clinical Research Nurse III - NIH/NCI HIV and AIDS Malignancy Branch

Job ID: req2850
Employee Type: exempt full-time
Division: Clinical Research Program
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.
 

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., the Clinical Research Directorate (CRD), various clinical support teams provide high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Mental Health (NIMH) and the National Institute of Environmental Health Sciences (NIEHS). CRD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CRD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CRD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Research Directorate (CRD) provides clinical research nursing support for the National Cancer Institute (NCI), Center for Cancer Research (CCR), HIV and AIDS Malignancy Branch (HAMB).

KEY ROLES/RESPONSIBILITIES

  • Alerts physicians of adverse events, abnormal outcomes or problematic trends, adhering to protocol mandates and ensures proper and timely filing of these occurrences
  • Creates and maintains IRB database of approved amendment descriptions
  • Assists the Principal Investigator (PI) in data collection (including patient specimens) and data analysis; writing interim reports, annual protocol reports, and scientific publications; interpretation of research data for the protocol team; and performing site visits
  • Completes flow sheets and case report forms according to the provisions of approved investigational protocols
  • Coordinates Clinical Trial Agreement requirements with applicable Clinical Research Oversight Managers (e.g., safety reporting requirements) and data management if data is to be provided to third party at end of trial
  • Works with the Clinical Trials Management Research Oversight Manager to ensure consistency of case report forms with the management plan and coordinate site initiation and other monitoring site visits with all necessary parties
  • Appropriately screens and collects blood samples from patients and donors per protocol schema
  • Collaborates with the patient’s community physician and other health care providers to further the continuity of care and protect the integrity of the clinical research trial/data
  • Conducts updates for clinical staff on patient care, protocol process and progress, human subject’s protection, ICH GCPs, and quality assurance education
  • Coordinates patient schedules and provides information for a successful visit to meet the required protocol procedures, data collection time points and nursing care
  • Defines, establishes, and manages inclusion criteria such as patient population, diagnostic criteria, and patient condition
  • Develops patient rapport and assists in explaining the protocol and tests/procedures to the patients
  • Discusses toxicities experienced and drugs/dosages received by patient while at home
  • Maintains communication with the patient’s home physicians to ensure any ongoing home care is in accordance with the protocol guidelines
  • Recruits and enrolls patients
  • Assists in the identification of the responsible party for data input into ClinicalTrials.gov at study conclusion, as applicable
  • Participates in quality improvement and quality assurance initiatives involving database and data system development efforts as well as training programs for research nurses
  • Collects and interprets data as specified by the investigators in support of the clinical trial including drug administration, toxicity, laboratory parameters and response interpretation
  • Collects and maintains current regulatory documentation from numerous ongoing clinical trials
    Interacts with auditing and monitoring agencies to facilitate the exchange of data
  • Interfaces with the Protocol Support Office
  • Manages dose modifications and/or other modifications of the treatment regimen made in response to toxicity, pharmacokinetics, and tissue studies
  • Manages implementation, tracking, data abstraction, collection, data reporting and coordination of a variety of Phase III clinical trials
  • Obtains informed consent
  • Serves as liaison between investigators, the IRB, and the study DSMB
  • Works with site staff to put systems in place to ensure timely resolution of queries
  • This position is location at the National Institutes of Health (NIH) in Bethesda, Maryland

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of a bachelor’s degree in a related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Additional qualifying experience may be substituted for the required education
  • Must possess a degree or diploma from a professional nursing program approved by a legally designated State accrediting agency at the time the program was completed
  • Current State license as a registered nurse (RN)
  • Foreign degrees must be evaluated for U.S. equivalency
  • In addition to the educational requirements, a minimum of five (5) years nursing and/or related clinical research experience
  • Knowledge of clinical research data collection and clinical data report preparation
  • Demonstrated experience in the coordination, implementation, and execution of clinical trials
  • Ability to work in a data management setting in the capture and analysis of patient data including toxicity assessment, drug administration, laboratory results, and tumor response
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • HIV and AIDS experience
  • Experience in a clinical trials outpatient setting and/or experience in data management and collection

To apply, please do so here

Frederick National Laboratory

Clinical Project Manager II - REMOTE

Job ID: req3039
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

 

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, tuberculosis, malaria and other infectious diseases and viruses such as hepatitis C and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRPD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical support to the NIAID Division of Microbiology and Infectious Disease (DMID) supporting clinical research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics. 

KEY ROLES/RESPONSIBILITIES

  • Provides collaborative leadership and management oversight and coordination of research projects and other initiatives
  • Performs a significant level of project/program management activities including utilizing project/program management tools and techniques to organize, plan, execute, report, and evaluate program objectives
  • Participates in the execution of projects and provides technical guidance in the development of administrative and operational processes, templates, procedure manuals, and other documents
  • Provides support to the development and implementation of various operational plans and technical/logistical tracking systems to meet research and operational needs
  • Monitors progress against plans and key deliverables
  • Manages project risk by proactively anticipating issues and develops contingency plans and solutions
  • Maintains coordination and communication between research operations, program management, project stakeholders and team members, and acts as liaison between government customers and subcontractors on behalf of CMRPD
  • Manages various subcontract planning, development, and implementation activities, including preparing statements of work and evaluating proposals
  • Oversees and monitors the technical work of subcontractors, performs review and verification of subcontractor deliverables and invoices, and monitors scope and budget
  • Collates, reviews, and analyzes metrics to ensure key clinical trial project timelines are met, and identifies trends and opportunities for improvement
  • Reviews and/or develops operational processes, procedures, and documents required to manage projects effectively, including study planning, start up, implementation and close out
  • Manages protocol-related document translations
  • Works with CMRPD financial analysts to manage budget development, cost estimating, and forecasting
  • Prepares and reviews progress reports
  • Supervises, either directly or indirectly, multiple levels of staff
  • Assists in the development of meeting agendas
  • Position may travel 10-20% domestically and internationally

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of a Bachelor's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research/clinical trials/health (Additional qualifying experience may be substituted for the required education)
  • Foreign degrees must be evaluated for U.S. equivalency
  • A minimum of five (5) years of progressively responsible, relevant experience in clinical research, including a minimum of two (2) years directly managing multiple concurrent clinical projects
  • Extensive experience in contract management and reporting
  • Previous project management and/or study coordination experience including data management and research subcontracting
  • Experience overseeing the work of subcontract CROs and vendors
  • Excellent written and oral communication skills including strong report writing and presentation skills
  • Strong interpersonal and cross-cultural communication skills
  • Knowledge and understanding of International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines, regulatory, ethics and other requirements for domestic and international studies
  • Expertise in analysis, planning, and problem solving
  • Strong organizational skills with the ability to prioritize and manage multiple tasks with a high degree of accuracy and attention to detail
  • Ability to work effectively both independently and as a team member with consistent ability to take initiative and make an active contribution to the team's performance
  • Demonstrated proficiency in Windows® and Microsoft® Office Suite including Word®, Excel®, Project®, and Outlook®
  • Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Clinical Research or Project Management Professional with infectious disease experience
  • Experience managing all facets of Phase I trials
  • Familiarity with the management of study products and supplies
  • Familiarity with Federal Acquisition Regulations (FAR)
  • Knowledge of Microsoft Project or other project tracking software

JOB HAZARDS

  • Employee would receive vaccinations required and determined by Occupational Health Services (OHS) and/or mandated by Federal Health Standard Regulations as needed for international travel

To apply, please do so here.

Frederick National Laboratory

Title: Clinical Project Manager IV - REMOTE
Job ID: req2915
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: USA
The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

 

PROGRAM DESCRIPTION

Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRPD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.

The Clinical Monitoring Research Program Directorate (CMRPD) provides comprehensive clinical support to the NIAID Division of Microbiology and Infectious Disease (DMID) supporting clinical research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics. 

KEY ROLES/RESPONSIBILITIES

  • Provides the operational leadership, overall management, and coordination of multiple DMID high-profile, domestic, and international clinical research projects
  • Supervises staff with a diverse range of expertise to include but limited to, administrative, project management, business operations, clinical research operations and trial management, biostatistics, and data management
  • Works closely with program and project leadership to develop overarching project plans, sets expectations for operational performance and provides oversight and technical expertise in the implementation and execution of project/program strategy
  • Develops trust and confidence with DMID staff and partners to foster highly collaborative and productive research initiatives, programs, and networks
  • Supports and facilitates the coordination of communication between research operations, program management, project stakeholders and team members, and between government customers and subcontractors
  • Engages with research partners to ensure expectations are clear, mutual, and appropriate, as well as identifies resources and support required by partners to achieve success
  • Performs a significant level of project/program management activities including utilizing project/program management tools, techniques, and principles to organize, plan, execute, monitor, report, and evaluate program objectives including identification of critical paths, resource restrictions, and decision points
  • Reviews and/or assists with the development of protocols, operational processes, procedures, and documents such as manual of operations, standard operating procedures (SOPs), quality management plans, laboratory instruction manuals, pharmacy plans, etc. for the effective management of protocols/study operations from planning through closeout.
  • Oversees Leidos Biomed and subcontractor deliverables
  • Participates in site-assessment activities to examine research competencies and capabilities and providing input for training and capacity building to meet protocol requirements and enhance performance
  • Oversees the development of training materials for delivery to research staff and study teams on conference calls and in-person
  • Facilitates the identification of project risks including those associated with timelines, scope, and budget, proactively anticipating issues, and collaboratively developing contingency plans and solutions
  • Oversees contract planning, development, implementation activities, and overall management, including reviewing statements of work, identification, and selection of vendors, evaluating proposals, developing/monitoring budgets, and monitoring addressing performance concerns.  Vendor services may include clinical operations, site management, data management, biostats, safety, IRB, trial monitoring, central or specialty laboratories, etc. for all clinical study Phases
  • Reviews and approves progress and program reports, special reports and budget documents as requested
  • Identifies appropriate resources, organizes project teams, and directs the work of other project managers to ensure staff continuity so deadlines, assignments and objectives are met
  • Contributes to organizational development activities including strategy management and operational planning related to routine review and evaluation of goals and performance metrics to ensure mission alignment with overall strategic plans within CMRPD and NIAID/DMID
  • Interacts with CMRPD and Leidos Biomed senior leadership by participating in budget development and contract review and management for Leidos Biomed Task Orders with the government
  • This position may travel up to 10% domestically and internationally
  • This position maybe remote within the US

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: 

  • Possession of Master's degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) Foreign degrees must be evaluated for U.S. equivalency
  • In addition to educational requirements, a minimum of ten (10) years of progressively responsible and responsive experience, achievement, and organizational visibility in project management, including at least eight (8) years directly managing multiple concurrent clinical trial projects
  • Ability to drive projects to completion by proactively coordinating the efforts of external and internal partners, within reasonable budgetary restrictions, and in compliance with deadlines and regulatory and client requirements
  • Ability to work in a clinical trial setting both independently and within a team of technical specialists and project leaders
  • Ability to apply working knowledge of clinical research relative to timetables to assess overall project timeliness and risks
  • Excellent communication skills (verbal and written) with the ability to develop project management staff
  • Ability to judge, organize, prioritize, and assign multiple tasks/projects with simultaneous orientation to detail and vision to understand the high-level interrelationships between the organization and the client
  • Must be detail oriented. Possesses strong organizational skills and the ability to prioritize multiple tasks and projects
  • Previous project management and/or study coordination experience including data management and research subcontracting
  • Possesses extensive knowledge of Food and Drug Administration (FDA) regulations and Good Clinical Practices (GCPs)
  • Knowledge of clinical trial fieldwork concepts and practices, specifically international clinical research guidelines related to site management requirements
  • Experience related to clinical operations (e.g., development of Standard Operating Procedures [SOPs], staff development and training, resourcing/staffing, and budget planning and execution)
  • Financial management experience as it relates to project, study, and subcontractor budgets and cost tracking
  • Ability to work well under pressure
  • Ability to apply technical expertise and make sound decisions
  • Ability to influence without authority
  • Flexibility and willingness to adapt in a changing environment
  • Ability to work independently and as a team member with consistent ability to take initiative and make an active contribution to the team's performance
  • Demonstrated success in previous positions in deployment and implementation processes
  • Experience supervising a clinical trials team containing multiple management levels
  • Demonstrates independent thought and leadership
  • Proficiency in Windows® and Microsoft® Office Suite including Word®, Excel®, PowerPoint®, and Outlook®
  • Must be willing and able to travel internationally
  • Ability to obtain and maintain a security clearance


PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Possession of a (CHEA) Doctorate degree from an accredited college/university in a field related to clinical research/project management
  • Experience managing a team of project managers
  • Clinical Research or Project Management Professional with infectious disease experience
  • Experience in an emerging disease/rapid response environment
  • Experience with Smartsheet
  • Familiarity with Federal Acquisition Regulations (FARs)
  • Familiarity with the management of study products and supplies, experience conducting federally funded research studies, experience in overseeing the work of subcontractors and/or vendors, knowledge of Microsoft Project or other project tracking software

To apply, please do so here

Meris Clinical Research

Meris Clinical Research is associated with a large pulmonary and sleep private practice with three locations within the Tampa Bay area. We are searching for a Clinical Research Coordinator to add to our team. The primary work location for this position will be at the Brandon Office.

Clinical Research Coordinator Duties and Responsibilities
 Support and coordinate day-to-day clinical trial activities
 Work with and train research volunteers about the trial and participation rules
 Oversee medication administration or device usage
 Conduct data collection and record reported results, as well as volunteer information
 Provide guidance on compliance with various guidelines and communicate any concerns
 Daily recruitment involving chart review and subject facing interactions

Clinical Research Coordinator Requirements and Qualifications
 Medical assistant or LPN
 Bilingual preferred
 Phlebotomy, Spirometry, and ECG experience preferred
 CCRC or willingness to become certified once qualified, preferred
 Proficient in Microsoft Office programs
 Attention to detail
 Ability to work independently
 Communication and interpersonal skills
 Working knowledge of clinical trial protocols, medical terminology, and GCP, IRB and FDA
policies

To apply, send your application to Andrea Thompson (athompson@pasotb.com) and Roland Bulnes (rbulnes@pasotb.com)

BLUEBIRD BIO

Position Title: Clinical Trial Manager, Clinical Trial Strategy & Execution (remote-based)
Department: Clinical Development Operations

Description (summary)

Responsible for overseeing all aspects of clinical study management for a gene therapy product. Able tosuccessfully manage a complex study with minimal supervision. Responsibilities include study planning and execution, timelines, budget, clinical site and vendor management. Comfortable working independently, managing interactions with experienced clinical monitors, and cross-functional internal/external project stakeholders.

Specific Job Duties

  • Responsible for the clinical trial being managed to the highest quality.
  • Responsible for all aspects of study planning and execution (in support of Regulatory filings), such as
  • timelines, budget, team management, and vendor oversight, with a focus on inspection readiness.
  • Accountable for the performance and delivery of all trial activities, including oversight and management ofcomplex, cross-functional study level issues. Value, promote and recognize performance achieved through teamwork and collaboration. Presents work to Program Team or other groups/ committees when requested.
  • Responsible for the preparation and communication of study documents and plans. Provide training for team members, including vendors.
  • Utilize experience to influence and lead a cross-functional internal/external team, including meeting leadership.
  • Ensure subject enrollment, data deliverables, study reports, and milestones are achieved on time &budget.
  •  Lead and own formal risk assessment activities, contingency planning, escalation, and approve corrective
  • action plans. Assist the CRA team when issues arise or deliverables are at risk.
  • Execute on study data deliverables. Review study data, communicate study status, risks, and issues effectively
  • both internally and with outsourced partners.
  • Facilitate and/or make study level decisions, drive difficult discussions to resolution. Accountable for CTSE
  • driven study decisions and actions.
  • Implement new processes and procedures per SOPs and regulations/guidance.
  • Promote the exchange of ideas, information and feedback in all directions. Proactively and respectfully
  • address issues and challenges directly, promoting conflict resolution at the team level. Escalate to manager when issues cannot be resolved directly with peers.
  • Lead discussions and anticipate questions in advance. Take broad topics and logically present information to convey clear, key messages. Able to adapt personal communication style to suit the situation. Seek to understand others with diverse viewpoints and experiences.
  • Clinical Subject Matter Expert for internal/external audits and agency inspections
  • Prioritize relationship management between Study Investigators/staff, vendors, KOLs. Partners with cross-functional team members to foster these external relationships.
  • May perform clinical site activities, such as on-site monitoring, co-monitoring, training, and motivational visits. Presents at clinical sites whenever needed.
  • Overcome challenges associated with cultural differences on a global study.
  • Work independently, escalate issues and reach out for support when needed
  • Travel (domestic and international) may be required

Required Education, Experience, or Qualifications (or equivalent)

  • Bachelor’s degree, in a life science preferred
  • 5-7 years clinical experience (biopharma, CRO, healthcare), with at least 2 years of managing cross-functional
  • project teams. Monitoring experience preferred.
  • In-depth knowledge & expertise in technical aspects of managing clinical trials and cross-functional study
  • teams.
  • Proven ability to identify study priorities, key stakeholders, define goals, and drive/achieve results through cross- functional study team.
  • Connect study deliverables to a comprehensive timeline and budget.
  • Excellent knowledge of current regulations and ICH/GCP.
  • Experience and understanding of global clinical study operations in rare diseases, pediatrics, and/or bone
  • marrow transplant experience welcome
  •  Experience with all aspects of study and site startup and vendor management
  • Experience with BLA submissions, regulatory agency inspections preferred
  •  Familiarity with clinical data review and data management processes, including Data Monitoring Committees
  • Strong verbal and written communication skills
  • Ability to work on teams with aggressive timelines and to multi-task in an extremely fast-paced and dynamic
  • environment with changing priorities
  • Independently motivated to learn and lead with minimal direction needed. Detail oriented.
  • “Do-what-it-takes” approach to problem solving, creative and prospective thinking
  • Ability to work effectively in a collaborative team environment where results are achieved through influence
  • and the incorporation of multiple points of view

Contact
This is a remote, 6-month contract position with an option to continue. To apply, please submit a copy of your CV/resume directly to Judith Tauriac, Associate Director, Clinical Trial Strategy & Execution at judith.tauriac@bluebirdbio.com.

To learn more about bluebird bio visit us at
https://www.bluebirdbio.com/.

PAREXEL

APEX CRA Program (CRA I)
United States - Northeast - Remote

The Accelerated Program of Education, Exposure, and Experience for CRAs (APEX CRA) provides foundational clinical research training - including project and system experience - to new hires who are recent college graduates and have less than a year of monitoring experience. Through this program, you will transform into a credible and experienced CRA I.

 

What you need to get started

  • Minimum Bachelor’s degree in life sciences/data sciences/pharmacy/nursing or other related discipline
  • Less than 6 months of clinical experience
  • Strong interpersonal, written, and verbal communication skills within a matrixed team
  • Experience working in a self-driven capacity, with a sense of urgency and limited oversight
  • A client-focused approach to work and flexible attitude with respect to assignments/new learning
  • The ability to manage multiple tasks, evaluate unpredictable scenarios and achieve project timelines while applying your understanding of study protocol(s)
  • An honest and ethical work approach to promote the development of life changing treatments for patients
  • Strong computer skills and aptitude to learn quickly

To apply, please do so here

 

CARE ACCESS

JOB TITLE: Data/Quality CRC

REPORTS TO: Lead Data Manager

CLASSIFICATION:  Full time

DESCRIPTION:

Works with the clinical research teams to promote quality assurance through activities related to data management, query resolution, quality check of source, communication with onsite and remote staff to ensure highest quality of data. This person will ensure quality measures and KPI’s are met and maintained.

DUTIES INCLUDE, BUT NOT LIMITED TO:

  • Ability to maintain data integrity, resolve queries and assist with data entry in a timely manner
  • Proficient working knowledge of various electronic data capture systems
  • Excellent attention to detail to perform quality control checks of source documentation
  • Ensuring data collection is accurately entered into research documents and documents adhere to quality and compliance standards
  • Perform a quality review of study documents prior to final version submission
  • Support clinical teams with preparations of audit or inspection readiness
  • Review Source Documents, medical records and essential documents of a specific study
  • Process checklists and standards according to GDP and GCP standards
  • Partner with the clinical research teams to drive quality assurance activities
  • Support multiple teams and departments
  • Provide guidance for adherence to all regulations, guidelines, and SOPs

ROLE REQUIREMENTS:

  • Strength in communication, planning, and time management skills
  • Strong People Skills
  • Willingness to travel if needed

KNOWLEDGE, SKILLS AND ABILITIES:

  • Excellent working knowledge of medical and research terminology
  • Excellent working knowledge of federal regulations, good clinical practices (GCP)
  • Ability to communicate and work effectively with a diverse team of professionals
  • Strong organizational skills: Able to prioritize, support, and follow through on assignments
  • Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients and vendors
  • Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals
  • Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel
  • Ability to balance tasks with competing priorities
  • Critical thinker and problem solver
  • Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done
  • Friendly, outgoing personality; maintain a positive attitude under pressure
  • High level of self-motivation and energy
  • Ability to work independently in a fast-paced environment with minimal supervision
  • Must have a client service mentality

EDUCATION/CERTIFICATION/LICENSE: EXPERIENCE:

  • A minimum of 2-4 years of relevant work experience
  • College degree or equivalent of education and experience
  • Research experience
  • Office/business skills

To learn more and apply, please click here.

 

FHI 360

Director, Clinical Regulatory and Compliance

Job Requisition: Requisition - 2022201258 Director, Clinical Regulatory and Compliance (Open) 

Job Family: Legal/Compliance 

Start Date: 08/16/2022

Job Summary:

Oversees clinical research, regulatory compliance, and research document management including the establishment of appropriate policies and standard operating procedures. Oversees internal and external quality assurance/audits of clinical trials and supporting functions. Manages National Institutes of Health (NIH) research financial conflicts of interest process and catalogue of the organization’s human subject research projects. Selects, develops, evaluates, and manages staff of Regulatory Affairs/ Quality Assurance/Records Management division.

Accountabilities:

  • Directs and develops programs and processes to meet management objectives and compliance with government agencies.

  • Oversees coordination and preparation of regulatory submissions to government agencies.

  • Serves as the liaison to the Food & Drug Administration (FDA) and other regulatory agencies on matters related to one or more studies.

  • Develops and manages budget for organizational unit and reports status to management.

  • Advises/coaches staff to ensure compliance with internal and external policies, laws, and regulations.

Applied Knowledge & Skills:

  • Comprehensive knowledge of theories, concepts and practices with regulatory agencies and compliance management.

  • Excellent and demonstrated project management skills.

  • Excellent oral and written communication skills.

  • Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of studies/project goals.

Education:

  • Bachelor's Degree or its International Equivalent

  • Life Sciences, Communications, Journalism, Public Health or Related Field.

Experience:

  • Typically requires a minimum of 10+ years of regulatory affairs and compliance management experience (including a minimum 5+ years of experience in a senior management/leadership position).

  • Prior experience with managing a staff and interacting with the FDA and international regulatory agencies.

Typical Physical Demands:

  • Typical office environment.

  • Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.

  • Ability to sit or stand for extended periods of time.

  • Ability to lift/move up to 5 lbs

To learn more and to apply, please click here