Regulatory Affairs Manager, Clinical Research

UF ECE Ambassadors; Gainesville (FL); On-site; USD 88,000 - 95,000; Full time

Benefits offered by this job

Excellent benefits

Retirement options

Paid leave

Job summary

UF Health Cancer Institute seeks a Regulatory Affairs Manager to lead regulatory compliance operations within the Clinical Research Office. The role oversees IRB processes and manages a team supporting cancer clinical trials.

Responsibilities include guiding investigators on federal regulations, supervising staff, and ensuring CTMS and documentation readiness. This management position emphasizes leadership in an academic healthcare research setting.

Qualifications

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

Skills

NCTN/ECTCN trials

Project management

Time management

Interpersonal skills

Regulatory knowledge

Leadership

Education

Master’s degree in Regulatory Affairs

Bachelor’s degree in a related field

Job description

UF Health Cancer Institute seeks a Regulatory Affairs Manager to lead regulatory compliance operations within the Clinical Research Office. The role oversees IRB processes and manages a team supporting cancer clinical trials.

Responsibilities include guiding investigators on federal regulations, supervising staff, and ensuring CTMS and documentation readiness. This management position emphasizes leadership in an academic healthcare research setting.