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Oncology Research Specialist / RN - Atrium Health Levine Cancer Clinical Trials FT
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Full-time
- Assists with the coordination of clinical, regulatory, business, and other research- related activities and documentation for clinical trials conducted by the Levine Cancer Institute, following industry standards and applicable regulations including FDA/OHRP guidances, GCP and ICH.
- Assists with clinical, regulatory, business, and other documentation associated with oncology research projects/clinical trials within LCI.
- Maintains protocol amendments, deviations, and informed consent changes regarding oncology research studies, assuring all documentation is managed compliantly and maintained in an audit-ready manner.
- Maintains appropriate documentation, (i.e. FDA Form 1572, CTSU documentation, IRB approval letters, ICFs, etc.)
- Completes registration for patient enrollment and maintains status in sponsor and LCI databases.
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