Regulatory Specialist, Senior
CurrentThe Christ Hospital Institutional Review Board (IRB). Coordinates regulatory affairs of The Christ Hospital Human Research Protection Program (HRPP). Maintains institutional and IRB policies and procedures; interprets and applies federal, state, and institutional regulations and policy promoting ethical practices in research; ensures compliance by faculty and staff investigators. Documents regulatory activities; organizes and participates in audits, quality reviews, and inspections. Develops written guidelines and educational materials for investigators and the research community. Partners with components of The Christ Hospital HRPP including Institutional Review Board members and staff, ancillary and administrative units, Legal Counsel, Compliance, Patient/Guest Services, and IT Security to facilitate research that is ethically and scientifically sound, meets legal and regulatory obligations, safeguards the rights and welfare of research participants, and fosters compliance, quality, and efficiency.