Regulatory Specialist

Job Summary

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. The 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.

Responsibilities

• 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. Prepares and manages 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. Communicate with outside entities (sponsors, CROs) and other UCSF departments (like finance, CTSI, OCTA, pharmacy, and clinical specialty departments).
• 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.
• Develops and implements systems to create, organize, update, audit, and archive study files and prepares them for monitor visits. Provide trainings to research team on regulatory requirements for study files and other regulatory issues.
• Collaborate with other UCSF specialties and departments, including, Radiology, laboratories, pharmacy, and others. Coordinate start up of new studies, including IRB submissions, budget, contracts, and other requirements of the startup process.
• Other administrative duties as needed to support the Clinical Trials team.

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