Regulatory Specialist

UCSF • San Francisco, CA

3d • $80,000 - $120,000 • Onsite

About The Position

The Regulatory Specialist role involves managing or performing the administrative services or managing the full general operations of an academic or non-academic organization(s). Administrative services include activities in finance and human resources and may also include IT, facilities, or student services. General management activities include long and short range strategic planning in determining the mission and directing all activities of multi-disciplinary departments through subordinate management staff. The Regulatory Specialist will use skills as a seasoned and experienced professional to oversee the regulatory operations of the Memory and Aging Center Clinical Trials Program and to contribute to the general administrative operations of the program. They will report to the Research Nurse Manager of the program and will work 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. The regulatory specialist 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, will thrive in a fast-paced environment, possess exceptional organizational and communication skills, demonstrate good judgment in prioritizing multiple competing deadlines, and has a passion for contributing to impactful medical research.

Requirements

• Seasoned and experienced professional skills
• Exceptional organizational skills
• Exceptional communication skills
• Good judgment in prioritizing multiple competing deadlines

Nice To Haves

• Collaborative
• Thrive in a fast-paced environment
• Passion for contributing to impactful medical research

Responsibilities

• Oversee the regulatory operations of the Memory and Aging Center Clinical Trials Program.
• Contribute to the general administrative operations of the program.
• Manage regulatory compliance for investigator-initiated and industry-sponsored clinical trials.
• Ensure compliance with institutional, federal, and sponsor requirements.
• Coordinate the preparation and submission of regulatory documents to IRBs, sponsors, and regulatory agencies.
• Collaborate closely with principal investigators, study teams, study sponsors, and administrative offices to facilitate timely study activation and maintain ongoing regulatory compliance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed