Job Board
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AVAILABLE JOBS
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CLINICAL RESEARCH COORDINATOR - Durham, NC
Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
Description of Clinical Responsibilities:
Type of Research:
This full-time onsite Clinical Research Professional (CRP) will support research led by the Principal Investigators (PIs) in the Division of Nephrology. This CRP will engage with community stakeholders, focusing on recruitment and retention in diverse communities. They will easily liaise with, engage with, and gain the support of the African American community for the purposes of conducting clinical research while maintaining Duke's core values including respect, trust, inclusion, excellence and professionalism. Working closely with the PIs, clinical staff, and other members of the research team, this CRP will perform EMR review, participant screening, travelling for screening events as needed, consenting, enrollment, study visits in the healthcare setting as well as in the community, collection/processing/management of specimens in compliance with sponsor, regulatory, and institutional guidelines, study and site documentation, data collection, query resolution, IP management, IRB/regulatory submissions and maintenance, and participant payment processing. This position supports a range of studies, including industry, federal, foundation, and investigator initiated. This CRP will directly report to the CRC, Sr. The Principal Investigators will provide ultimate supervision, regulatory oversight, mentorship, and guidance in the conduct of research.
Review full job details here: https://careers.duke.edu/job-
Manager, Bioanalytical Services - US, New York, NY, Whitesboro Onsite
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
At ICON, it’s our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn’t mean you can’t have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
The Laboratory Manager will be responsible for designing, developing and conducting a variety of cell-based screening assays including neutralizing antibody assays. Work closely with customers to assist in the transfer, development and validation of these types of assays in a GxP-compliant manner.
Review full job details here: https://careers.iconplc.com/
Senior Manager, Bioanalytical Services - US, New York, NY, Whitesboro Office
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a People Leader, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• *Interact with site management and provide guidance for client project managers over specific aspects of studies.
• Responsible for ensuring appropriate staffing levels to deliver financial budgets including increasing and reducing/reallocating/redeploying staff when required.
• *Responsible for ensuring that appropriate technical, communication and commercial skill sets exist in at their department.
• *Attend client meetings, and any other relevant study related meetings.
• *Management of managers, laboratory supervisors, principal scientists, and other members of staff.
• Development and review of SOPs and other controlled documentation.
• *Adherence to GLP and the SOPs pertaining to work conducted within their department.
• *Regular review, analysis and reporting of revenue forecasts including pipeline outlook.
• *Ongoing review of procurement and overhead costs across their department to ensure overhead is in line with business activity (e.g. consumables, utilities, capital, travel, other overhead).
• Monthly review of income statements before submission to divisional leaders (either along with or before review by the VP of Bioanalytical Services).
• To undertake other reasonably related duties as may be assigned from time to time.
• Travel (approximately 15%) domestic and/or international
Review full job details here: https://careers.iconplc.com/
Manager, Scientific Affairs - Hybrid
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Manager, Scientific Affairs to join our diverse and dynamic team. As a Manager, Scientific Affairs at ICON, you will lead strategic initiatives to support scientific communication, medical education, and knowledge dissemination across global markets.
What you will be doing
• Develop and implement strategic plans for scientific communication and medical education initiatives.
• Lead the creation of scientific content, including publications, presentations, and educational materials.
• Establish and maintain relationships with key opinion leaders (KOLs), academic institutions, and professional societies.
• Provide scientific expertise and support to cross-functional teams, including medical affairs, marketing, and regulatory affairs.
• Stay abreast of emerging trends and developments in the scientific and healthcare landscape
Review full job details here: https://careers.iconplc.com/
Principal Scientist - US, New York, NY, Whitesboro Office-based
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Review full job details here: https://careers.iconplc.com/
Senior Director, Design Control- Cambridge MA- Hybrid
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
- Lead and manage the IVD design control team, providing direction, support, and mentorship.
- Develop and implement strategic plans for IVD design control activities in alignment with company objectives and ensure all IVD design control activities comply with applicable regulations and standards including assay development and validation and kit production.
- Core understanding of the medical device regulatory process in collaboration with Regulatory Affairs and provide essential support during internal and external audits and inspections by supplying necessary documentation and addressing findings related to design control and regulatory compliance.
- Ensure the IVD design control processes comply with relevant regulatory requirements, including FDA, ISO 13485, IVDR, CLIA, and other applicable standards.
- Establish and maintain IVD design control procedures, templates, and tools.
- Ensure robust ISO14971 risk management processes are integrated into the design and development phases and risk management is performed
- Oversee the development of design history files (DHFs) and technical files (TFs) to ensure completeness and accuracy. Plan and conduct design phase review meetings
- Lead IVD design control activities for new product development projects, ensuring timely and compliant progression through design phases.
- Coordinate with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and Manufacturing, to ensure cohesive and compliant product development.
- Monitor project timelines, budgets, and resource allocation to ensure projects are completed on time and within budget and oversee the project management team for assay development.
- Drive periodic improvement initiatives to enhance IVD design control processes, efficiency, and product quality.
- Implement lessons learned from post-market surveillance and product performance to improve IVD design control practices.
- Develop and deliver training programs on IVD design control requirements for internal teams.
- Promote a culture of quality and compliance within the organization through regular communication and training.
- Expected travel needs approximately 25%.
Review full job details here: https://careers.iconplc.com/
CRA II Biotech - United States - Remote
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate to join our diverse and dynamic Biotech team that is therapeutically aligned in our Gen Med space. As a Clinical Research Associate , you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where We work as one team to achieve industry-leading results.
What You Will Be Doing:
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Working independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation
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Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
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Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required
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Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness
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Dependent on level of experience you may assist in training and mentoring less expert CRA’s and/or lead CRA’s working on international projects
Review full job details here: https://careers.iconplc.com/
Clinical Trial Manager II Biotech - United States -Remote
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a CTM II to join our diverse and dynamic Biotech team with a therapeutic alignment of Gen Med. As the CTM II, you will hold a crucial role in ensuring the successful delivery of all clinical aspects of the studies.
What You Will Be Doing:
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Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation.
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Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight.
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Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance.
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Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines.
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Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary.
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Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams.
Review full job details here: https://careers.iconplc.com/
Senior Scientific Manager - Medical Communications
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
US - Remote
(Preferably NE US)
As a Senior Scientific Manager, extensive prior experience and in-depth knowledge concerning all aspects of developing and executing the diverse array of deliverables within medical publications and medical communications is expected and will be an integral and required foundation for this role. Additionally, as a senior account team leader, other requirements include being team focused and setting an example for cooperation to create trust and work towards common goals and values. Responsible for attendance at project meetings and for providing status reports at these meetings regarding projects in progress.
Attend off-site meetings as required.
Being able to adapt to changes in plans and priorities and exercise good judgment is important. Based on this overall description, the SSM role will fall broadly across the following approximate allocations (individual client account teams may have, from time to time, specific needs that may alter these allocations as may be necessary/required)
Review full job details here: https://careers.iconplc.com/
Clinical Research Nurse I - US, San Antonio, TX Office-based
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Nurse I to join our diverse and dynamic team. As a Clinical Research Nurse I at ICON, you will play a pivotal role in supporting the execution of clinical trials, ensuring adherence to protocol requirements, and providing compassionate patient care throughout the research process.
What You Will Be Doing:
- Assisting in the planning, implementation, and coordination of clinical research activities in accordance with study protocols, regulatory guidelines, and standard operating procedures (SOPs).
- Conducting patient assessments, administering study treatments, and performing clinical procedures as required by the research protocol, while ensuring patient safety and compliance with ethical standards.
- Collecting, recording, and maintaining accurate and complete data documentation, including medical histories, vital signs, adverse events, and laboratory results, in electronic case report forms (eCRFs) and study databases.
- Collaborating with multidisciplinary teams, including investigators, study coordinators, and regulatory staff, to ensure efficient study conduct, participant recruitment, and retention throughout the duration of the trial.
- Providing education and counseling to study participants and their families regarding study procedures, treatment regimens, and informed consent, while addressing any questions or concerns that may arise during the course of the study.
Review full job details here: https://careers.iconplc.com/
SMA I - US - Hybrid - Raleigh, NC, Wilmington NC, Blue Bell, PA, Lenexa, KS
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Site Management Associate to join our diverse and dynamic team. The Site Management Associate is responsible for managing, implementing and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations.
What You Will Be Doing:
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Identifying, training/initiating and closing out of study sites.
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Managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained.
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Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed.
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Maintains Sponsor and patient confidentiality
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Actively participates in regular meetings with Project Managers
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Assists in development of site and patient enrolment strategies with project team; works to motivate sites to meet enrolment timelines.
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Developing knowledge of and compliance with local regulatory requirements.
Review full job details here: https://careers.iconplc.com/
Associate Vice President – Clinical Research – Government Contracting (REMOTE – U.S. Based)
Westat’s Health Sector is seeking a highly motivated and experienced Associate Vice President (AVP) with strong business development, client management, project leadership, and clinical research experience to join our leadership team in the Clinical Research Practice. You will have a proven track record in spearheading business development in clinical research, with significant experience managing large-scale projects and securing contracts with federal agencies. The AVP will be responsible for helping to grow our Department of Health and Human Services (HHS) portfolio by leading various capture activities and directing existing or new projects of varying sizes.
Review full job details here: https://sjobs.brassring.com/TGnewUI/Search/home/HomeWithPreLoad?partnerid=82&siteid=5197&PageType=JobDetails&jobid=922647
Principal Scientist - US, NY, Whitesboro Office-based
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.
Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.
That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.
Review full job details here: https://careers.iconplc.com/job/principal-scientist-in-us-new-york-ny-whitesboro-jid-37704
Medical Technologist (I, II, and Senior) - Farmingdale, NY - Office-based
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Department: Our lab continues to grow and we are currently seeking Medical Technologists (All levels) for each of the following departments: Chemistry, Hematology, Special Chemistry, Immunology, and Flow Cytometry. These positions are hired specifically for the department and are not floating positions.
Hours: Full-time, 40 hours per week, Dayshift 10am-630pm, Tuesday through Saturday
Position Overview:
We are seeking a talented and motivated Medical Technologist to join our Icon Central Laboratory team in Farmingdale, NY. In this role, you will play a key role in supporting our clinical research efforts by conducting laboratory tests, analyzing data, and ensuring compliance with regulatory requirements.
Review full job details here: https://careers.iconplc.com/job/medical-technologist-i-ii-and-senior-in-us-new-york-ny-farmingdale-jid-35968
Laboratory Supervisor - Farmingdale, NY
The University of Kansas Cancer Center
The University of Kansas Cancer Center is the only National Cancer Institute designated Comprehensive Cancer Center in our region, 1 of only 57 in the nation to receive this distinction. Patients gain access to the most promising therapies, cutting-edge clinical trials and world class research. We are an employer of choice offering our employees competitive salaries and excellent State of Kansas benefits.
If you are interested in being a part of an organization making a difference in the lives of others, please go to: https://www.kucancercenter.org/careers/research-jobs for a complete listing of our openings. Feel free to reach out to Alana Estes, Sr Recruiter at aestes@kumc.edu with any questions. The current open roles are not eligible for relocation assistance.
Also, check out all the research opportunities available with The University of Kansas Medical Center at: https://www.kumc.edu/human-resources/careers.html
Senior Clinical Research Scientist
The Senior Clinical Research Scientist develops and independently writes clinical documentation including clinical protocols, clinical study reports and clinical justifications in support of research and new product development, registration and commercialization of products.
This position is part of Clinical Affairs team and will be hybrid to Sunnyvale, CA. The senior clinical research scientist will work on advanced, complex projects requiring state of the art knowledge in oncology and/or infectious disease molecular diagnostics. This is an exciting opportunity to collaborate with other members on the cross functional team.
Lecturer in Physiology
The role
The School of Physiology, Pharmacology, and Neuroscience at the University of Bristol is seeking to appoint a Lecturer in Physiology (ACAD107454). You are expected to have a track record of high-quality research in that focuses on using in vivo approaches to investigate systems/integrative physiology or experimental medicine. This may be applied to: exercise, metabolism and nutrition; cardiopulmonary control; thermoregulation; autonomic control of organ dysfunction in health and disease; or metabolomic investigations of clinical disorders that can link into our research themes including (but not limited to) cardiovascular, respiratory gastrointestinal and renal conditions, diabetes or rheumatoid arthritis. An interest in the development of bio-informatic approaches would be desirable, as would development of research programmes with clinical academic researchers if appropriate.
Clinical research site coordinators – your feedback is requested.
If you are a clinical research site coordinator supporting clinical trials in
neurology, we invite you to complete this brief pre-screening survey to
determine your eligibility to participate in a 60-minute interview.
Please scan the QR code to complete the pre-screening survey; you will
receive a $25 Amazon gift card for your time.
Older
Clinical Monitoring Associate (East) - Remote
Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Exciting opporuntity for a recent graduate that is pursuing a career in clinical research!!!
Responsibilities
What you will be doing:
- Learn and assimilate knowledge about clinical trial procedures and operations, Good Clinical Practices, and regulatory requirements.
- Support the team in basic administrative tasks and documentation, under supervision.
- Participates in site feasibility and/or pre-trial site assessment visits, providing input on site/investigator selection in collaboration with the trial team, under supervision.
- Attends investigator meetings as needed for observational purposes.
- Supports activities related to site initiation and start-up, site monitoring, site management and site-study close-out according to internal and client SOPs, working practices, working Instructions, guidelines, applicable regulations, and the principles of ICH-GCP, under supervision.
- Supports local project planning activities in conjunction with the primary Clinical Research Associate to meet recruitment targets and to deliver high quality data on time and per the monitoring plan requirements.
- Supports site staff training activities and accurate filing of documentation of training, under supervision.
- Confirms site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct, under supervision.
- Confirms that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and documented. Arranges for appropriate destruction of clinical supplies, under close supervision.
- All Serious Adverse Events/Product Quality Complaints are to be reported within reporting timelines and documented as appropriate. The CMA will also ensure that they are consistent with all data collected and with the information in the source document under close supervision of the primary site CRA.
- Under close supervision, confirms site staff completes data entry and resolves queries within the expected timelines.
- Under close supervision, confirms accuracy, validity and completeness of data collected at trial sites
- Under close supervision, participates in the full documentation of trial related activities, in particular monitoring- confirmation letters/visit reports/follow-up letters and the upload into eTMF.; Assist in organizing and maintaining study documentation, understanding the importance of accurate record-keeping.
- Under close supervision, promptly communicates relevant issues and status information to appropriate trial team members.
- Complies with relevant training requirements to learn about compliance, safety reporting, monitoring skills, therapeutic area, sponsor processes and regulatory requirements to conduct a trial.
- Develops an understanding of the various stakeholders.
- Engage in team meetings, contribute ideas, and gain exposure to cross-functional collaboration within the work environment.
- Observe monitoring activities (site selection, site initiation, on-site monitoring, remote monitoring, and close-out visits) learning how to conduct these types of visits, interact with site personnel and document observations.
Qualifications
You are:
- New college graduate, graduating no more than 12 months prior to their start date, with a Bachelor’s or Master’s degree (e.g., BS, MS), in Sciences/Health Sciences or related field.
- GPA 3.0 minimum
- Maintain patient, organization, and client confidentiality
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Clinical Monitoring Associate (West) - Remote
Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
Exciting opporuntity for a recent graduate that is pursuing a career in clinical research!!!
Responsibilities
What you will be doing:
- Learn and assimilate knowledge about clinical trial procedures and operations, Good Clinical Practices, and regulatory requirements.
- Support the team in basic administrative tasks and documentation, under supervision.
- Participates in site feasibility and/or pre-trial site assessment visits, providing input on site/investigator selection in collaboration with the trial team, under supervision.
- Attends investigator meetings as needed for observational purposes.
- Supports activities related to site initiation and start-up, site monitoring, site management and site-study close-out according to internal and client SOPs, working practices, working Instructions, guidelines, applicable regulations, and the principles of ICH-GCP, under supervision.
- Supports local project planning activities in conjunction with the primary Clinical Research Associate to meet recruitment targets and to deliver high quality data on time and per the monitoring plan requirements.
- Supports site staff training activities and accurate filing of documentation of training, under supervision.
- Confirms site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct, under supervision.
- Confirms that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and documented. Arranges for appropriate destruction of clinical supplies, under close supervision.
- All Serious Adverse Events/Product Quality Complaints are to be reported within reporting timelines and documented as appropriate. The CMA will also ensure that they are consistent with all data collected and with the information in the source document under close supervision of the primary site CRA.
- Under close supervision, confirms site staff completes data entry and resolves queries within the expected timelines.
- Under close supervision, confirms accuracy, validity and completeness of data collected at trial sites
- Under close supervision, participates in the full documentation of trial related activities, in particular monitoring- confirmation letters/visit reports/follow-up letters and the upload into eTMF.; Assist in organizing and maintaining study documentation, understanding the importance of accurate record-keeping.
- Under close supervision, promptly communicates relevant issues and status information to appropriate trial team members.
- Complies with relevant training requirements to learn about compliance, safety reporting, monitoring skills, therapeutic area, sponsor processes and regulatory requirements to conduct a trial.
- Develops an understanding of the various stakeholders.
- Engage in team meetings, contribute ideas, and gain exposure to cross-functional collaboration within the work environment.
- Observe monitoring activities (site selection, site initiation, on-site monitoring, remote monitoring, and close-out visits) learning how to conduct these types of visits, interact with site personnel and document observations.
Qualifications
You are:
- New college graduate, graduating no more than 12 months prior to their start date, with a Bachelor’s or Master’s degree (e.g., BS, MS), in Sciences/Health Sciences or related field.
- GPA 3.0 minimum
- Maintain patient, organization, and client confidentiality
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Clinical Pharmacology Director - Home-Based (US)
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
- Provide clinical pharmacology support for programs through the worldwide marketing application filing, including supportive registration documents and presentations.
- Review and prepare documents for regulatory submission, including clinical development plans, Investigator’s Brochure, and the Clinical Pharmacology section of INDs, CTAs, and/or NDAs.
- Contribute to the clinical pharmacology sections of regulatory documents, including Investigator Brochures, documents for regulatory meetings, NDA/BLA/MAA.
- Participate in designing the overall clinical pharmacology plan for the different steps of clinical development, according to the strategy developed by the Company.
- Write and review scientific documents, such as Clinical Study Protocols, Standard Operating Procedures (SOPs), Statistical Analysis Plans, and Clinical Study Reports
- Collaborate with cross-functional teams, including clinical, clinical operations, regulatory affairs, and biostatistics, to ensure the successful execution of clinical trials
- Ensure the successful preparation and presentation of all internal and external documentation relating to clinical pharmacology.
- Development and execution of clinical pharmacology strategies for late-stage development programs from Proof-of-Concept (Phase 2a) through worldwide marketing application.
- Oversee population PK, ER, c-QTc analyses conducted by the vendors and perform PK NCA analysis/fit-for-purpose PK/PD simulation if needed.
- Provide expert PK/PD advice to cross-function project teams.
Qualifications
- Advanced degree (PhD, PharmD, MSc) in Pharmacology, Pharmaceutical Sciences, or related field.
- Minimum of 5 years of experience in clinical pharmacology in the pharmaceutical industry.
- Strong knowledge of PK/PD principles and their application to clinical pharmacology.
- Familiarity with PK/PD software (e.g. WinNonlin, NONMEM, Monolix, R, etc) and working knowledge of MIDD concepts.
- Experience in oncology small molecule development is preferred.
- Experience in regulatory submissions and interactions with regulatory agencies.
- Experience in clinical pharmacology study design and interpretation.
- Experience in clinical pharmacology data analysis and reporting.
- Excellent written and verbal communication skills.
- Ability to work independently and as part of a team.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles
Beckman Coulter Diagnostics
Job Title: Staff Clinical Project Manager
Location – USA Remote
Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Staff Clinical Project Manager for Beckman Coulter Diagnostics is responsible for managing the In-Vitro Diagnostic clinical research for the Neurodegenerative Disease portfolio.
This position is part of the Clinical Affairs department located in Chaska, MN and will be Remote. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the Clinical Affairs Team and report to the Senior Manager of Clinical Affairs responsible for In-Vitro Diagnostic Clinical Research. If you thrive in an innovative, dynamic role and want to work to build a world-class Clinical organization—read on.
In this role, you will have the opportunity to:
- Design and lead early phase clinical research focused on neurodegenerative disease clinical evidence planning and portfolio development.
- Develop clinical strategy, protocol design, case report form and informed consent design.
- Manage clinical study timelines, resource demand and budget across the disease portfolio.
- Develop internal and external partnerships to ensure stakeholder satisfaction.
- Support good clinical practice and scientific integrity concepts.
- Proactively identify and resolve business challenges and/or regulatory issues.
The essential requirements of the job include:
- Bachelor’s Degree in field with 14+ years of experience or a master’s degree with 12+ years of experience or PhD/MD degree with 9+ years of experience
- Experience designing sponsored clinical studies for in vitro diagnostic (IVD), pharmaceutical, or medical device.
- Advanced knowledge of Good Clinical Practice and global IVD medical device
- Experience developing regulatory strategy as it relates to clinical study design and negotiating with regulatory agencies as a subject matter expert.
- Experience in neurodegenerative disease clinical research
It would be a plus if you also possess previous experience in:
- Experience working with external strategic partners.
- Experience collecting real world evidence.
At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.
The annual salary range for this role is $150 - $200 K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
If you’ve ever wondered what’s within you, there’s no better time to find out.
To apply by sending updated resume to: Patina Jackson at patina.jackson@danaher.com and use external link to apply.