Oversees and directs the coordination of clinical research components as they relate to investigational products under the purview of the FDA, RAC and OBA Assists the VP, Clinical Research Regulatory & Quality Management (CRRQM) as needed with the development, implementation and maintenance of the St. Jude Children's Research Hospital clinical trials regulatory compliance program to assure adherence to local, state and federal regulations and institution policies and procedures for the responsible conduct of institutional clinical research activities. Represents St. Jude Children's Research Hospital as a point of contact with regulatory authorities for questions and issues regarding specific applications. Coordinates and executes the assembly and approval of drug/biologic/device applications to regulatory authorities, including the collection, collation of data/information, and writing needed to complete an application. Coordinates with other CTA staff to improve the quality of applications and proposes improvements to the regulatory application process.
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