Clinical Regulatory Affairs Lead—IRB & Trials

University of Florida; Gainesville (FL); Vor Ort; USD 88.000 - 95.000; Vollzeit

Zusammenfassung

University of Florida is seeking a Regulatory Affairs Manager on the UF Health Cancer Institute team at the Gainesville campus to lead regulatory compliance for cancer clinical trials. You will oversee IRB submissions, renewals, and documentation, while mentoring regulatory staff and guiding investigators on federal and sponsor requirements.

The role emphasizes collaboration across multidisciplinary clinical research teams, development of SOPs, and ensuring audit readiness, CTMS compliance, and

Qualifikationen

• Master's degree in appropriate area of specialization; or a bachelor's degree in appropriate areas of specialization and two years of experience.
• Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc.) are required at the earliest of 12 months from hire or eligibility.

Aufgaben

• 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 CTMS compliance.
• Developing and implementing standard operating procedures, workflow improvements, and compliance monitoring strategies to support research excellence and operational efficiency.

Kenntnisse

Leadership

Regulatory Affairs

IRB

Team Management

Clinical Research

Communication

Project Management

Ausbildung

Master's degree in appropriate area of specialization

Bachelor's degree in appropriate areas of specialization + 2 years experience

SOCRA/ACRP certification

Jobbeschreibung

University of Florida is seeking a Regulatory Affairs Manager on the UF Health Cancer Institute team at the Gainesville campus to lead regulatory compliance for cancer clinical trials. You will oversee IRB submissions, renewals, and documentation, while mentoring regulatory staff and guiding investigators on federal and sponsor requirements.

The role emphasizes collaboration across multidisciplinary clinical research teams, development of SOPs, and ensuring audit readiness, CTMS compliance, and