This position involves preparing and submitting protocols and supporting documents to regulatory bodies and agencies, such as the CHLA Institutional Review Board (IRB), External IRB, Clinical Radiation Safety Committee, Institutional Biosafety Committee (IBC), and any other research committees involved in regulatory review and approval processes. The Regulatory Coordinator Sr also submits continuation reviews, amendments, responds to questions from sponsors, institutional departments, or regulatory bodies, generates reports, and maintains research files and documentation required for the study or clinical trial.