Study Activation Coordinator

The Study Activation Coordinator provides comprehensive regulatory coordination for clinical research studies across assigned units, departments, or divisions. This role is responsible for study regulatory activities for study activation, ensuring strict adherence to federal, state, sponsor, and institutional requirements.

Under general supervision, the Study Activation Coordinator performs detailed reviews of clinical research protocols and translates protocol requirements into actionable regulatory and activation plans. You will prepare, submit, and maintain all required regulatory documentation to support study start-up and ongoing compliance, including submissions to Institutional Review Boards (IRBs), the FDA, sponsors, and internal UCLA committees and ancillary services. During study activation, the coordinator develops activation project plans, drafts informed consent forms, coordinates site initiation visits, secures required approvals, and ensures all regulatory and financial documents are complete and compliant. Throughout the life of the study, the role manages protocol amendments, regulatory submissions (e.g., deviations, SAEs, safety reports, renewals), monitoring visit preparation and follow-up, and maintenance of regulatory binders and records. The analyst serves as a liaison among investigators, sponsors, regulatory agencies, institutional partners, and study teams to ensure timely communication and compliance.

The position also supports quality assurance and audit readiness activities, maintains documentation within the Clinical Research Management System (CRMS), and proactively applies evolving regulatory knowledge to ensure continuous compliance. This role is regulatory-focused and does not include patient-facing or direct data management responsibilities. It is critical to maintain compliant, efficient study activation and oversight within a high-volume clinical research environment.

Salary Range: $31.51 -  $62.64/Hourly