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Clinical Trial Associate, Study Start up
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Full-time
- Reports to: Senior Clinical Specialist, Study Start Up
- The Clinical Trial Associate, SSU will aid in study start up activities for Fractyl's global clinical program, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals.
- Support the Clinical Operations team in the successful execution of clinical trials from protocol concept to clinical trial report, complying with international ICH/Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs)
- Help Sr Specialist manage IRB/EC and regulatory submission and approvals, including amendments and continuing reviews
- Maintain SSU documents in internal TMF and maintain inspection ready documentation
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