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Regulatory Operations Manager - Pediatric Oncology Clinical Research Program
Reporting to an Associate Director within the Clinical and Translational Investigative Program (CTIP) and the specific disease center, the Regulatory Operations Manager (ROM) is responsible for supporting disease groups research portfolio; managing the development and quality control of protocol documents prior to IRIS and/or CHeRP submission, assisting with New Protocol Application (NPA) vetting and prioritization, ensuring that IRIS and CHeRP submission, review and approval timelines / institutional benchmarks are met.?? This position is the primary point person responsible for the collaboration / navigation with the Dana-Farber Cancer Institute (DFCI) and Boston Children???s Hospital (BCH) IRB contacts, clinical trial sponsors, the designated Principal Investigator and th
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