Regulatory Compliance Specialist

Job Summary

Working remotely on a full-time basis, the Regulatory Compliance Specialist will prepare and oversee research-related regulatory documents, coordinate submissions to regulatory bodies, and manage compliance documentation for clinical trials.

Key responsibilities

• Prepare, maintain, and oversee all research-related regulatory documents
• Coordinate the submission process of initial regulatory documents to the IRB, sponsors, and regulatory offices
• Compile and submit initial, continuing, and final reports to the IRB and/or sponsor

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