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Clinical Research Compliance Specialist
2 months ago
At Cooper University Health Care, we prioritize exceptional health care through our dedicated team. Our professionals are at the forefront of clinical advancements, ensuring access to the latest facilities, technologies, and research protocols. We are committed to our employees by offering competitive compensation, comprehensive benefits, and opportunities for professional growth.
Discover why Cooper University Health Care is recognized as a leading employer in South Jersey.
Position OverviewThe Clinical Research Compliance Specialist will oversee and participate in all Institutional Review Board (IRB) and Executive Committee meetings; support research investigators and study coordinators in the submission of research proposals; evaluate and monitor new protocol submissions, amendments, adverse event reports, and progress reports; prepare and distribute review materials, agendas, and minutes of IRB meetings to all members; generate correspondence to investigators based on determinations made by expedited reviewers or the Board; facilitate the distribution of research protocols for administrative review and signatures; inform investigators of impending study expirations; manage and maintain the electronic system and study files (both online and paper) that document protocol activities; provide guidance and consultation to IRB members and investigators regarding federal regulations, state laws, and Cooper IRB policies and procedures; and assist the IRB Manager and Chairs with special projects.
Key skills include:
- Exceptional written and verbal communication abilities.
- Strong time management capabilities.
- Ability to collaborate effectively within a team.
- Commitment to delivering outstanding customer service.
- Proficiency in MS Office applications and the MS Windows operating system.
- Familiarity with Sitero Mentor is preferred.
- Knowledge of New Jersey laws and regulations related to human research is highly preferred.
- Certification as an IRB Professional (CIP) is preferred.
The Clinical Research Compliance Specialist will conduct local context reviews of studies ceded to external IRBs. Responsibilities include organizing, tracking, and maintaining records of all reliance agreements and covered research activities. The role involves providing summary reports and metrics to the Director of the Human Research Protection Program (HRPP) and Cooper leadership upon request. Additionally, the Specialist will coordinate and oversee institutional responsibilities outlined in agreements and/or dictated by federal, state, or local laws and policies. This may include verifying training of the research team, reviewing consent forms for local context, assessing financial disclosures for conflicts of interest, ensuring completion of local ancillary reviews, and reviewing reports of unanticipated problems or suspected non-compliance.
Required ExperienceIn-depth knowledge of the Common Rule (45 CFR 46), FDA regulations, ICH Good Clinical Practice Guidelines, and other relevant requirements and guidelines related to the ethical study of human research subjects.
Educational QualificationsA Bachelor's degree in a relevant field or an equivalent combination of education and experience is required.
A minimum of 2 years of experience in IRB administration, clinical research, or regulatory compliance involving human subjects is essential.
