Clinical Regulatory Manager at Saint Louis University in SLU Saint Louis, MO

Job description

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 SUMMARY The Clinical Research Regulatory Manager oversees clinical research regulatory activities across all units supporting industry-sponsored, National Institutes of Health (NIH), and other grant-funded studies at Saint Louis University. This position promotes compliance with applicable federal and state regulations, institutional policies and procedures, and requirements governing human subjects research. The manager coordinates regulatory submissions and Institutional Review Board (IRB) review processes, monitors submission status and documentation requirements, and supports compliance with approved research protocols and applicable regulatory standards. The role also contributes to clinical trial oversight, coverage analysis development, clinical trial contract and budget coordination, regulatory policy and procedure development, and staff training. Working collaboratively with principal investigators, physicians, clinical research coordinators, university offices, sponsors, and external research partners, the Clinical Research Regulatory Manager facilitates efficient regulatory workflows, supports timely study activation and ongoing compliance, and promotes consistent regulatory practices across clinical research activities. The position requires a strong working knowledge of Food and Drug Administration (FDA) regulations and applicable human research protection and Good Clinical Practice (GCP) guidelines. PRIMARY JOB RESPONSIBILITIES Regulatory Submissions and IRB Coordination: Coordinate the preparation, completion, and submission of initial and continuing review applications and other required regulatory documentation to the Institutional Review Board (IRB). Monitor submission status, identify outstanding requirements, follow up with investigators and study coordinators, and communicate action items to facilitate timely review and maintain ongoing compliance. Regulatory Compliance and Oversight: Support compliance with applicable federal and state regulations, FDA requirements, human subjects protection standards, institutional policies, and approved study protocols. Identify outstanding regulatory requirements and work collaboratively with research teams to facilitate appropriate and timely resolution. Clinical Trial Coverage Analysis: Assist in developing and reviewing clinical trial coverage analyses in accordance with applicable federal Medicare coverage and billing guidelines, collaborating with relevant stakeholders to support appropriate research-related billing practices. Clinical Trial Contracts and Budgets: Facilitate the review and processing of clinical trial contracts and budgets in collaboration with principal investigators, sponsors, and appropriate internal and external university offices. Clinical Trial Registry Oversight: Serve as the university administrator responsible for compliance oversight of the applicable national clinical trials registry, supporting accurate, complete, and timely registration and reporting in accordance with relevant requirements. Policy and Procedure Development: Contribute to the development, review, implementation, and evaluation of regulatory policies, procedures, and workflows. Promote consistent documentation practices and continuous improvement of regulatory processes across clinical research units. Training and Staff Development: Provide onboarding, guidance, and training support to clinical research regulatory coordinators, including newly assigned coordinators. Reinforce regulatory workflows, documentation standards, institutional procedures, and the effective use of research systems. Clinical Trial Monitoring and Coordination: Particip