Description

Description The Regulatory Compliance Coordinator I works with investigators, consortiums, and the Clinical Trials Office infrastructure to develop new clinical trials. The individual will be expected to act as the main contact during the protocol development phase, correspond with the reviewing committees and personnel, assist in budget development by identifying research non-billables, and coordinate start-up meetings for new protocols. Responsibilities 1. Protocol development: Work with investigators to create new protocols, informed consent forms, case report forms, and additional study documents, as needed per protocol. 2. Tracks new protocols through the committee system to approval, responds to committees' inquiries. 3. Gathers data needed to prepare and process applications for IRB review and approval. 4. Collaborates with the Principal Investigator (PI) in completion of application documents including all required PPHS paperwork, for approval of new clinical research trials. 5. Coordinates conference calls with investigators to aid in study development. 6. Obtains IND# for the clinical trials through correspondence with the FDA, ...