Role OverviewThe 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.
What You Will Do
Coordinate regulatory submissions, Institutional Review Board (IRB) review processes, monitor submission status, and support compliance with approved research protocols and applicable regulatory standards.
Why It Might Be a Fit
This role requires a strong working knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and human subjects protection standards.
Requirements
- Associate degree
- Five years of related experience, primarily in clinical research, including at least two years of regulatory compliance experience
- Prior experience preparing and submitting applications to an Institutional Review Board (IRB)
- Proficiency in Microsoft Office applications, particularly Word and Excel, and the ability to use Adobe Acrobat and DocuSign for research documentation and related workflows
Benefits
- Dental insurance
- Vision insurance
- Health insurance
- Life insurance
- Retirement plan
- Paid time off
- Holidays
- Professional development opportunities
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