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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
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Ann & Robert H. Lurie Children's Hospital of Chicago
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Regulatory Coordinator
Responsibilities The Regulatory Coordinator will work with the Network Clinical Research Team and UCLA study teams that support the JCCCClinical Research Unit, the UCLA/Translational Research in Oncology-US, Inc. (TRIO-US), and the Community Oncology ResearchNetworks, in the set-up and conduct of network clinical trials. Assist with the coordination of study regulatory set-up for all Network clinical trials. Work with the UCLA Study Teams and Pharmaceutical sponsors and CROs in preparing, compiling and shipping required regulatory documents. Respond to and resolve sponsor queries-written and verbal, and assist with the review and preparation of Network site study consent forms. Prepare and submit Network site study-specific regulatory documents to cen
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