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

All Required:

• Bachelor's degree in related area and/or equivalent combination of education and experience.
• Minimum of 1+ years of experience as a clinical researcher.
• Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.
• Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations.
• Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
• Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment.
• Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met.
• Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.
• A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently.
• Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws.
• Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.