Job Board

We are happy to announce our new Job Board in staying with our mission to create diversity opportunities in the Clinical research industry. All job sponsors are committed to creating an inclusive workplace. If you are interested in receiving notifications on new job postings please subscribe. If you are interested in being featured on the job board please contact info@bwicr.com.

Please review the BWICR job posting price list here. 

AVAILABLE JOBS

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

The Henry M. Jackson Foundation

Clinical Research Assistant II

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.

HJF is seeking a Clinical Research Assistant II to perform data collection by conducting research interviews. Recruits and screens subjects for the ADEPT study. Collects baseline and follow up data from subjects. 

Responsibilities

• Performs data collection by conducting research interviews. Recruits and screens subjects for research studies. Collects baseline and follow up data from subjects. Checks for validity and accuracy of data ensuring compliance with quality assurance requirements and clinical relevance.
• Establishes and maintains database files and progress reports for studies, projects and programs. May perform data analysis and interpretation.
• Performs scientific literature searches, identification and retrieval.
• Performs administrative duties such as: assisting in developing and submitting grants, papers and abstracts, manuscripts and presenting studies, developing protocol manuals and data collection instruments; participates in field visits; responds to requests and questions from individuals, institutions, government agencies and funding agencies and participates in the design of research studies.

Required Knowledge, Skills and Abilities

• Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
• Ability to use measurable and verifiable information for making decisions or judgments.
• Excellent organizational and project management skills.

Work Environment

• This position will take place primarily in an office setting.

Education and Experience

• Bachelor's Degree Social Science (i.e., Sociology, Psychology) or related fields
• Minimum of 3 to 5 years experience required

All HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required. To learn more and to apply, please click here.

NurseNow Staffing

Position: Clinical Research Registered Nurse (Site based)

Location:  Winston Salem, SC

# of positions available: 1

Start: ASAP

Contract Length: 3 Months 

Hours:  Part Time – 20 hours per week

RESPONSIBILITIES:

• Conducting infusion - *Candidate must have recent infusion experience
• Unblinded IP coordinator duties with potential for assisting with blinded duties
• Recruiting patients
• Conducting visits
• Completing EDC/Queries/phone calls etc.

EDUCATION/LICENSING 

Must hold an active, unencumbered RN license to practice in SC

NurseNow Staffing

Position: Clinical Research Coordinator

Location:  Southern California

# of positions available: 3

Start: ASAP

Contract Length: 6 Months – temp to hire

Hours:  Fulltime Mon-Fri 8:30am-5pm

EXPERIENCE REQUIREMENTS:

• Minimum 3 years recent CRC experience
• Recent direct patient care experience in clinical research
• Direct experience enrolling patients into clinical studies working with PIs 
• Complete understanding of the complex process for enrolling patients into a phase 2 & 3 studies
• Experience collecting and reporting source documentation
• Experience conducting research visits
• Experience with patient scheduling
• Experience developing chemotherapy clinical research treatment plans
• Managed at least 4-6 studies independently over 3-4 years
• Knowledge of processing research specimens
• Knowledge of FDA, NIH and OHRP regulatory requirements and ICH and GCP guidelines
• Experience collecting and reporting source documentation
• Experience consenting patients
• Experience adverse event reporting
• Experience working with physician investigators processing blood collection samples
• Experience shipping dangerous goods
• Experience completing and submitting source data to sponsors

EDUCATION 

Minimum AA degree or ACRP or SoCRA certification

 

Circuit Clinical

Lead Research Coordinator 

Circuit Clinical

Manager of Clinical Trial Budgets & Billing

Job Description

Alcanza Clinical Research

Regional Director, Clinical Research Sites

Location: New England Territory

Travel Requirements: 50%

Looking to be part of something more meaningful? At Alcanca Clinical Research, you’ll be part of a team dedicated to providing clinical research options to all people and creating a meaningful impact on future treatments and therapy options in medicine.  Alcanza is the next-generation site network organized to support the most significant demands in our industry: diverse patient access, efficient enrollment performance, and clinical quality.  

We are currently seeking a Regional Director in our New England region who will lead and support our clinical research site locations.  In this newly created role, the overall responsibilities will include driving operational performance for the research sites while providing onsite leadership and oversight to help ensure streamlined coordination of clinical research activities. The ideal candidate will have prior multi-site research management experience and will report directly to the COO. In further detail, the candidate will be responsible for:

• Overall territory site management and leadership with a focus on driving site performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance
• Collaborating with other functional leaders in Business Development, Patient Recruitment, Budgets and Contracts and Quality to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets, etc.
• Reviewing the performance dashboards and other clinical trial systems to oversee site and patient activities, and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency)
• Using operational data, metrics and reports to identify opportunities in expanding operational output and risks to deliverables
• Overseeing resourcing allocations, site assignments and study team members' output and performance, to ensure study deliverables are on track, and identifying risks to delivery or quality.

Minimum Qualifications: 

A Bachelor’s degree and a minimum of 5 years of clinical research experience, or an equivalent combination of education and experience, is required. 

5+ years of management experience is required. 

2+ years of multi-site research management experience is highly preferred. 

An active driver’s license, in good standing, current car registration & auto insurance is required.  

Bi-lingual (English / Spanish) proficiency is preferred.

Required skills:

• Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm);
• Must possess strong organizational skills and attention to detail.
• Well-developed written and verbal communication skills.
• Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers.
• Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities.
• Must be professional, respectful of others, self-motivated, and have a strong work ethic.
• Must possess a high degree of integrity and dependability.
• Ability to work under minimal supervision, identify problems and implement solutions.
• Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines.

View the full job description here. For consideration, please send your resume and cover letter to hr@alcanzaclinical.com

Care Access

Site Services Relationship Manager (REMOTE)

Care Access is seeking a dedicated, experienced, and innovation-driven Site Services Relationship Manager. This position is fully remote and the successful candidate must meet the following requirements:

• You MUST have a minimum of 2 years of experience
• Previous experience as a Site Services Relationship Manager in Clinical Research is a plus
• 4-year degree
• Advanced knowledge in site services/account services/client services
• Previous experience in Clinical Research is a MUST
• Working business hours as agreed with the manager. 
• Travel is less than 5% if/when required
• You must have the authorization to work in the US for any employer
• You must not need visa sponsorship, either now or in the future

Role Requirements

• Strength in communication, planning, and time management skills
• Strong people skills
• Willingness to travel as needed
• 2-4 years in Clinical Research, Client Relationship Management, or Customer Success Role
• Attention to detail, ability to meet deadlines, and respond to sites in a timely manner
• Ability to handle pressure, juggle multiple responsibilities simultaneously, and work well with a diverse site and customer base with internal teams

Benefits Offered

• PTO/Vacation days, sick days, holidays
• 100% paid Medical, Dental, and Vision Insurance. 75% for dependents 
• HSA plan
• Short-term disability, long-term disability, Life Insurance
• Continued Education Allowance
• Culture of growth and equality
• 410K plan and matching contribution

For more details and applications, please click here.

Roswell Park Comprehensive Cancer Center

Clinical Chief and Leader of Translational Research in Breast Oncology

Only NCCN-Designated Comprehensive Cancer Center

Roswell Park Comprehensive Cancer Center is seeking a Clinical Chief to develop a robust translational research program in breast medical oncology. The successful candidate will join one of the top comprehensive cancer programs in the nation and harness the vast resources of Roswell Park to push forward the development of novel therapies to fight breast cancer. The new Clinical Chief will develop a nationally regarded program in translational research and early-phase clinical research in breast cancer. This will be fueled by a large untapped regional market of accruals and realized by the new leader's vision to put Roswell Park on the national map for breast cancer care. Candidates must be MDs or MD/PhDs at the Associate or Full Professor level with significant experience in translational research.

Opportunity Highlights

• Oversee all aspects of breast medicine oncology
• Set the clinical and scientific strategic goals for the Division with an emphasis on early-phase clinical research to enhance accrual of breast oncology patients to clinical trials and increase overall market share
• Use a vast amount of Roswell Park's resources to develop novel immunotherapy treatments in breast cancer
• Total commitment of executive leadership to build a world-class program in breast oncology translational research
• Become a nationally known leader in breast cancer research by developing your own team
• Build Roswell's reputation for developing cancer therapies in immunotherapy and promote its visibility in this area
• Participate in the education mission for fellows, residents, APPs, and faculty
• Roswell Park is the nation's first comprehensive cancer center and the only NCCN-designated center in Upstate NY
• Ranked among the nation's top cancer hospitals by US News and World Report
• Desirable location close to Toronto

Community Information
Live and work in the heart of a thriving medical corridor in a city that has undergone a significant transformation, building on its waterfront on the shores of Lake Erie. You'll enjoy historic architecture; affordable, charming, tree-lined neighborhoods; and proximity to Canada and the Toronto metropolitan area.

• World-renowned symphony orchestra, excellent art gallery, and dozens of universities and colleges, with national and international connections facilitated through the Buffalo Niagara International Airport
• A cost of living nearly 21% lower than the national average
• Excellent public and private schools
• Major league sports town with NFL and NHL team
• An abundance of outdoor recreation, including hiking, biking, paddle boating, and golfing
• Buffalo has an overall grade of A- (Niche)

For immediate consideration please inquire with an updated copy of your CV so we can discuss the position by phone. Also, inform me of your best available times to speak. I look forward to your reply and thank you for your review. Please do not delay as we anticipate a significant response.

Please contact David King at medcareers@merritthawkins.com or at 866-406-0269 and reference ON-117893

CenExel

Principal Investigator

Location: Orange County, California

CenExel, one of the nation’s top-ranked research institutions, is seeking a family medicine physician for a Principal Investigator research opportunity in highly desirable Orange County, California. The successful candidate will leave the hassles of private practice and work 40 hours per week doing medical research in clinical trials I-IV. Work with cutting-edge pharmaceuticals that are on the forefront of developing new medications and therapies that will change healthcare. Candidates with experience in clinical trials or a desire to learn are encouraged to apply.

Opportunity Highlights

• Significant income potential - $250,000+ with incentives + profit sharing
• Fantastic quality of life – 40 hours per week – Monday - Friday in sun-soaked Orange County with very light call (phone only)
• Work at a highly regarded research institution – facility is brand new with 120 beds and the latest high-tech equipment
• Perform clinical research for a nationally known research institution 
• Professionally trained research staff with years of experience
• Work on some of the newest pharmaceuticals and medical therapies 
• No business responsibilities = more professional balance and peace of mind

Community Information—Live and Work in Orange County, California!
Welcome to paradise. Orange County offers various activities and lifestyles perfect for families and individuals alike. Whether you’re looking to live in world-renowned beach communities, the Saddleback Mountain foothills, or somewhere more central, you’ll enjoy an incomparable quality of life in this sought-after Southern California location.

• Overall A grade and #3 best county for families in California (Niche)
• Some of the top public and private schools in the state
• Filled with cultural diversity, world-class shopping and dining, and entertainment options
• Ideal weather and consistent sunshine year-round, allowing for an abundance of outdoor recreation, including plenty of beach activities
• Myriad nearby family-friendly attractions, such as Disneyland and Knott’s Berry Farm
• Enjoy Laguna Beach, Huntington Beach, and the Balboa Peninsula in Newport
• Close to LA, including Universal Studios and Hollywood 
• Local collegiate and professional sports teams

For immediate consideration please inquire with an updated copy of your CV so we can discuss the position by phone. Also, inform me of your best available times to speak. I look forward to your reply and thank you for your review. Please do not delay as we anticipate a significant response.

Please contact David King at medcareers@merritthawkins.com or at 866-406-0269 and reference PINV-145413

Parexel Jobs

Senior/Principal Statistical  Programmer at Parexel

Location: Home Based USA

As a Principal or Senior Programmer you will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors. Parexel will provide you with the perfect opportunity to expand on your experiences and develop new skills in a stimulating work environment

If you are interested, you can read more here and apply!

 

Data Management Lead II / Senior Data Management Lead at Parexel

Location: USA - Any Region - Home Based

Bring your Data Management expertise to Parexel's Strategic Partnerships. Although we work globally, each partnership we form is deeply personal. We are as dedicated to every aspect of our client’s product development as they are – and work closely with client teams in true partnership to understand both challenges and opportunities. At Parexel we are focused on meeting customer and patient needs through collaborative partnership so that we get treatments into the hands of patients who need them most.

If you are Interested, you can read more here and apply!

 

Clinical Operations Assistant at Parexel

Location: USA - Any Region - Home Based

The role of the Clinical Operations Assistant (COA) is to maintain the paper and electronic Central Files for Clinical Operation, ensuring efficiency, accuracy and quality.

 

Depending on the location of the role may include the tracking, scanning, filing, entry and return of Case Report Forms to clients for assigned projects, upload and naming of documents to the electronic document management system, EDC User Management activities and activities associated with Impact Harmony, as appropriate.

If interested, you can read more here and apply:

Clinical Research Associate (CRA) at Parexel

Location: Home based - USA- Any region

At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build and maintain the site relationship and ensure they’re set up for success. As the clinical sites’ sole point of contact, this includes addressing and resolving site issues and questions. You’ll also manage site quality and delivery from site identification through to close-out.

 

As a CRA, Parexel will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers. Your hard work may be rewarded through a bonus incentive program, the opportunity to work within multiple therapeutic areas and an opportunity to advance your career in clinical research. If impact, flexibility, and career development appeal to you, Parexel could be your next home.

If you are interested, you can read more here and apply!