Program Manager, HRPP Regulatory Operations
Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation’s oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.JOB SUMMARYThe Program Manager, HRPP Regulatory Operations will be responsible for executing education program activities, conducting substantive pre-submission intake reviews, and providing IRB review and quality assurance support as it relates to the Human Research Protection Program (HRPP) at Saint Louis University. This position focuses on developing and implementing continuous improvement efforts related to human subjects research education and contributing to institutional initiatives to obtain and maintain Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation.PRIMARY JOB RESPONSIBILITIESExecutes and evaluates the education program to ensure research is conducted in accordance with applicable regulations, laws, and policies; monitors changes in laws, regulations, and technology and communicates potential operational impacts to management; identifies gaps in educational and training initiatives for researchers and develops resources, guidance documents, and support materials to meet research needs; maintains and tracks education program records that are subject to professional and technical auditReviews and processes incoming submissions by verifying compliance with unit policies and routing submissions to required University ancillary groups for review; conducts structured pre-submission intake reviews to provide investigators with early, substantive feedback to identify missing elements, clarify regulatory requirements, and improve submission quality before formal IRB assignment; uses patterns and trends identified through intake review to inform the development of targeted guidance documents, researcher training materials, and educational resources that address common submission deficiencies and regulatory misunderstandings; reviews post-approval submissions; processes out human subjects research applicationsConducts protocol review across all submission types in support of IRB review activities; may serve as a Designated Reviewer when formally appointed by the IRB Chair in accordance with IRB policies and procedures; assists with quality assurance activities related to researcher conduct of approved studies, including PI quality assurance reviews (QAR), for-cause and noncompliance audits, and CAPA development and monitoring for researcher-directed corrective actions; ensures appropriate separation of duties between IRB review and QA activitiesCoordinates Institutional Review Board meetings and other meetings as directed; contacts Board members to solicit timely submission of reviews; documents review determinations in protocol files; maintains committee rosters and facili...