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 regulatory bodies, and compile study information for reporting while ensuring compliance with all relevant regulations.

Key responsibilities

• Prepare and maintain all research-related regulatory documents and oversee their accuracy
• Coordinate the submission process of initial regulatory documents to the IRB and other regulatory offices
• Compile and submit necessary reports to the IRB and sponsors, including amendments and informed consent documents

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