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Regulatory Coordinator
1. Processes new protocols by preparing submission documents to the institutional review board (IRB). 2. Acts as a liaison between the Yale Cancer Center (YCC) and IRB to streamline the approval process by staying current with IRB requirements and addressing requests for revisions to protocol documents. 3. Processes all protocol amendments; prepare and submit protocol amendments to the Protocol Review Committee, ancillary review committees and to the IRB, update the clinical trial tracking system with submission and approval information, update the regulatory binders, and communicate with the appropriate YCC research, laboratory and pharmacy staff regarding amendment submissions and approvals, and track completion of amendment training of all study staff. 4. Processes annual renewal o
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