Regulatory Compliance Specialist
Job Summary
Seeking a remote full-time Regulatory Compliance Specialist I, the candidate will manage the preparation and oversight of research-related regulatory documents, coordinate submissions to IRBs and sponsors, and compile study information for reporting purposes.
Key responsibilities
- Prepare and maintain all regulatory documents related to clinical research
- Coordinate the submission process for initial regulatory documents to IRBs and sponsors
- Manage and archive clinical trial documents and prepare for monitoring visits and audits
Required qualifications
- Bachelor's degree or equivalent experience
- Minimum of 3 years' experience in clinical or biological research
- Exceptional knowledge of clinical research methods
- Proficiency in Microsoft Office applications (Outlook, Word, Excel)
- Industry certification as applicable
Complete Job Description
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