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Kelly Science & Clinical

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Regulatory Specialist
PURPOSE Under the administration of the Director of Regulatory Affairs, the Regulatory Specialist will contribute to the support of breast and colorectal cancer research and the management of clinical trials by preparing and coordinating protocol-related regulatory documents for new and existing Federal and Industry sponsored clinical trials and serving as a resource to staff and member institutions.    ESSENTIAL FUNCTIONS Regulatory Submissions and Protocol Maintenance Prepares documents including but not limited to drug applications, protocols, amendments, progress reports, safety report information for submission to applicable government agencies and Institutional Review Boards (IRBs) for obtaining


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