Description
The Senior Clinical Research Regulatory Coordinator supports clinical research teams by facilitating study-start-up approvals, maintaining regulatory compliance documentation, tracking IRB and subcommittee submissions, coordinating with investigators, sponsors, and oversight committees, and managing regulatory submissions, amendments, safety reports, and closure activities. The role also serves as a team leader and trains new regulatory staff. An associate degree or equivalent education and experience is required, a bachelor's degree is preferred, and more than one year of regulatory documentation experience in clinical research is required.
