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Regulatory Manager
Prepares informed consent documents describing complex protocols to our patients and their allies in an approachable manner, including descriptions of study procedures, risks, benefits, and financial considerations prior to participation. Composes IND and IDE applications to the FDA for all investigator-initiated drug and device studies; registers such studies on clinicaltrials.gov and assists with results reporting per FDAAA 801 requirements. Regularly interacts with institutional , state, and federal oversight/regulatory agencies for monitoring and protocol compliance purposes.
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