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Phase 1 Registered Nurse Oncology Research Specialist - Atrium Health Levine Cancer FT
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- 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.)
- Maintains patient shadow charts with appropriate source documentation.
- Completes registration for patient enrollment and maintains status in sponsor and LCI databases.
- Supports the clinical trial team to efficiently complete tasks including documentation/submissions, Serious Adverse Events (SAEs)/safety reports, FDA Form 1572, DARFs, ClinicalTrials.gov postings, etc.
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