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Research Nurse Coordinator RN - Oncology - MF 8 Hour Days
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- Submit protocol, informed consents and necessary documents to Institutional Review Board (IRB) for approvals; communicate with IRB on a regular schedule if applicable.
- Confirm that all regulatory documents are submitted to sponsor in a timely manner, e.g., 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as needed.
- Maintain strong working knowledge of Standard Operating Procedures (SOPs), FDA regulations, and International Conference on Harmonization/Good Clinical Practice (ICH/GCP) guidelines.
- Complete Case Report Forms (CRFs) and study related documents, submit documents to sponsor and/or IRB, if applicable.
- Perform yearly review of studies, completing yearly documents required by sponsor, IRB and FDA. Review case report forms.
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