Regulatory Affairs Team Lead

Job No: 538804

Work Type: Full Time

Location: Main Campus (Gainesville, FL)

Categories: Allied Health, Grant or Research Administration, Health Care Administration/Support, Legal/Audit Services/Compliance

Department:  - HA-UFHCI CRO REGULATORY

Classification

Title:

Clinical Research Coordinator III

Classification

Minimum Requirements:

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

The UF Health Cancer Institute is the 72nd NCI designated cancer center and the only one at a public university in the State of Florida. As a matrix cancer center, we span all of the University of Florida's 16 colleges, pulling together a world‑class, multi‑disciplinary membership of over 350 faculty and 150 staff to address the challenges of the cancer burden faced by the population we serve as we work together to find a cure.

As a Regulatory Affairs Team Lead at the UF Health Cancer Institute (UFHCI), you will be responsible for supporting the unit manager in overseeing regulatory compliance operations within the Clinical Research Office. Strong leadership, regulatory expertise, and the ability to collaborate across multidisciplinary clinical research teams are necessary for success in this role.

• Overseeing regulatory operations for clinical trial protocols, including IRB submissions, approvals, renewals, amendments, and regulatory documentation tracking.
• Leading, mentoring, and managing regulatory staff, including IRB Specialists and Assistants, while supporting staff development, training, and performance management.
• Providing regulatory guidance to investigators, research teams, and institutional partners to ensure compliance with federal regulations, sponsor requirements, and institutional policies.
• Directing portfolio oversight and quality assurance activities, including audit readiness, regulatory reporting, and clinical trial management system (CTMS) compliance.
• Developing and implementing standard operating procedures, workflow improvements, and compliance monitoring strategies to support research excellence and operational efficiency.

This is an senior‑level position, ideal for candidates with experience in clinical research regulatory affairs and human subjects research compliance. Employees in these roles operate as part of our collaborative research enterprise and are fundamental to the progress of cancer research being conducted at the University of Florida. A complete job description will be provided to candidates selected for interview.

Expected Salary: $68,000 - $75,000

This is a TEAMS position, and is eligible for a suite of excellent benefits, retirement options, and paid leave.

Home to the University of Florida, one of the nation's top public universities, Gainesville offers vibrant academic and healthcare communities alongside an affordable cost of living, no state income tax, and mild winters. Enjoy the outdoors with over 30 miles of bike trails, freshwater springs, and numerous water activities, plus easy access to beaches and world‑class theme parks.

Gainesville combines historic charm with modern amenities, including a great school system, a lively downtown, and farmers' markets and craft breweries. Discover professional growth and quality of life in Gainesville—where community, innovation, and work‑life balance meet!

For more information, check out:
The Guide to Greater Gainesville and Explore Gainesville in 60 seconds.

Required Qualifications:

• Bachelor's degree in Health Care, Public Health, or a related field.
• Regulatory or clinical trials coordination experience in an Academic Medical Center.
• Comprehensive and demonstrated understanding of Good Clinical Practice.

• Proficiency with databases and/or patient data
• Proficiency with Microsoft Office suite.

Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc.) are required at the earliest of 12 months from hire or eligibility.

Knowledge/

Experience:

• Master's Degree in Regulatory Affairs, Health Care, Public Health, or a related field.
• Six to…