Clinical Trials Regulatory Lead

Department Overview The UCSF Memory and Aging Center (MAC) is an internationally renowned clinical and translational research center located in the Sandler Neurosciences Building and other buildings on the UCSF Mission Bay Campus. MAC provides clinical care for patients suffering from neurodegenerative disorders. Our mission is to find effective and scientifically-based treatments that lead to a cure for neurodegenerative brain diseases. This is accomplished through clinical trials that emphasize patient and family benefits and public health impact, and observational studies that deepen our understanding of the biological mechanisms of neurodegenerative disease. Job Summary The Regulatory Specialist role involves managing and performing the administrative services or managing the full general operations of an academic or non-academic organization. The role oversees regulatory operations of the Memory and Aging Center Clinical Trials Program and contributes to general administrative operations. The specialist reports to the Research Nurse Manager and works closely with program leadership and other team members to manage regulatory compliance for investigator-initiated and industry-sponsored clinical trials. This role ensures compliance with institutional, federal, and sponsor requirements by coordinating the preparation and submission of regulatory documents to IRBs, sponsors, and regulatory agencies. Collaborates closely with principal investigators, study teams, study sponsors, and administrative offices to facilitate timely study activation and maintain ongoing regulatory compliance in a complex academic research environment. The ideal candidate is collaborative, thrives in a fast-paced environment, has exceptional organizational and communication skills, demonstrates good judgment in prioritizing multiple competing deadlines, and has a passion for contributing to impactful medical research. Responsibilities 50% Manages, plans and administers a range of administrative and clinical research operations for the Memory and Aging Center Clinical Trials Program with a focus on regulatory compliance, finance, staff training, and project management. Includes preparing and managing IRB applications, sponsor/CRO visits, and sponsor invoices. Plays a critical role in preparing for and participating in sponsor of FDA inspections or audits and budget management for protocols and the trials team. Effectively communicates with outside entities (sponsors, CROs) and other UCSF departments (finance, CTSI, OCTA, pharmacy, and clinical specialty departments). 20% Administrative operations include creation and maintenance of clinical trials regulatory binders including documentation on study trainings, financial disclosures, delegation logs, service certifications, and other key regulatory documents. 15% Develops and implements systems to create, organize, update, audit, and archive study files and prepares them for monitor visits. Provides trainings to research team on regulatory requirements for study files and other regulatory issues. 5% Coordinates start-up of new studies, including IRB submissions, budget, contracts, and other requirements of the startup process. Collaborates with other UCSF specialties and departments, including radiology, laboratories, pharmacy, and others. 10% Other administrative duties as needed to support the Clinical Trials team. Qualifications Required Qualifications Bachelor's degree. 3+ years of related work experience; and/or equivalent experience/training. Interpersonal skills including verbal and written communication, active listening, critical thinking, persuasiveness, advising and counseling skills. Ability to use discretion and maintain confidentiality. Strong skills in short-term planning, analysis, problem-solving, and customer service. Clinical research with FDA regulated studies experience. Experience with IRB preparation and management. Preferred Qualifications Thorough knowledge of University rules and regulations, processes, protocols and procedures for budget, accounting and 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. Clinical Trials experience, including working with study budgets, contracts, start-up, and regulatory documentation. Ability to prioritize when there are multiple competing deadlines. #J-18808-Ljbffr