Regulatory Affairs Team Lead

University of Florida•Gainesville, FL

8d•$68,000 - $75,000•Onsite

About The Position

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. In your new role you will be responsible for the following: 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.

Requirements

Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc.) are required at the earliest of 12 months from hire or eligibility.

Responsibilities

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.