Medical Director-IRB
Core
Provide administrative, ethical, and regulatory leadership for the institution's human subjects protection program, overseeing the review of all research involving human participants.
Role type
Senior IC medical director (IRB)
Builds
Ethical review processes and compliance frameworks for human subjects research
Domain
Healthcare + Regulatory Compliance
Required skills
Human subjects research regulations expertise, bioethics knowledge, protocol design advisory, risk mitigation strategy, regulatory interpretation, committee oversight
Preferred skills
Conflict resolution, advanced degree in scientific/medical/legal discipline
Technologies
DHHS 45 CFR 46, FDA 21 CFR 50/56, Belmont Report
Responsibilities
Preside over convened full-board IRB meetings and manage protocol discussions, Conduct expedited and exempt reviews and evaluate protocol amendments, Interpret and apply federal regulations and state statutes, Mentor and train IRB members and administrative staff, Advise investigators on protocol design and consent form requirements, Authorize suspension or termination of research approvals when required
Seniority
Senior, hands-on IC