California Licensed Regulatory Coordinator
Job Summary
To support clinical research compliance, the full-time California Licensed Regulatory Coordinator will prepare and submit protocols and supporting documents to various regulatory bodies while maintaining strict adherence to Good Clinical Practice (GCP) guidelines and HIPAA regulations in a fully remote capacity.
Key responsibilities
- Prepare and submit research protocols and documents to regulatory agencies, including IRBs and safety committees
- Manage continuation reviews and amendments, responding to inquiries from sponsors and regulatory bodies
- Generate reports and maintain comprehensive research files and documentation required for studies or clinical trials
Required qualifications
- 3 years of experience in healthcare, clinical research, or a related field
- Prior regulatory experience with document submissions to regulatory bodies
- Bachelor's Degree in a related field or equivalent combination of education and experience
Complete Job Description
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