Regulatory Specialist

Department Overview The UCSF Memory and Aging Center (MAC) is an internationally renowned clinical and translational research center with over 300 full‑time employees. The MAC provides clinical care for patients suffering from neurodegenerative disorders and conducts research in the Sandler Neurosciences Building and other UCSF Mission Bay Campus locations. Job Summary The Regulatory Specialist will manage regulatory operations of the Memory and Aging Center Clinical Trials Program and support overall administrative operations. Reporting to the Research Nurse Manager, the role coordinates regulatory compliance for investigator‑initiated and industry‑sponsored clinical trials, ensuring adherence to institutional, federal, and sponsor requirements. The position collaborates with principal investigators, study teams, sponsors, and administrative offices to facilitate timely study activation and maintain ongoing compliance in a complex academic research environment. Key Responsibilities Manages and administers a range of administrative and clinical research operations for the Clinical Trials Program, focusing on regulatory compliance, finance, staff training, and project management; prepares and manages IRB applications, sponsor/CRO visits, and sponsor invoices. Plays a critical role in preparing for and participating in sponsor and FDA inspections or audit events, and in budget management for protocols and the trials team. Creates and maintains clinical trials regulatory binders, including documentation on study training, financial disclosures, delegation logs, service certifications and other key regulatory documents. Develops and implements systems to create, organize, update, audit, and archive study files; prepares them for monitor visits and provides training to research staff on regulatory requirements. Coordinates startup of new studies, including IRB submissions, budget, contracts and other startup requirements, and collaborates with other UCSF specialties and departments. Performs other administrative duties as needed to support the Clinical Trials team. Required Qualifications Bachelor's degree. 3+ years of related work experience, or equivalent experience or training. Interpersonal skills: verbal and written communication, active listening, critical thinking, persuasiveness, advising and counseling. Ability to use discretion and maintain confidentiality. Strong skills in short‑term planning, analysis, problem solving, and customer service. Clinical research experience with FDA‑regulated studies. Experience with IRB preparation and management. Preferred Qualifications Thorough knowledge of University rules and regulations, processes, protocols and procedures for budget, accounting, fund management and/or personnel management. Knowledge of a variety of administrative operational activities such as event planning, basic fundraising processes, risk management planning, website design, accounting and payroll, and contracts and grants regulations and guidelines. Solid knowledge of common university‑specific computer application programs. Clinical trials experience. Project management experience. Ability to prioritize when there are multiple competing deadlines. #J-18808-Ljbffr University of California - San Francisco