Regulatory Affairs Supervisor

Job Summary

This position oversees their regulatory unit in the Cancer Clinical Trials Office (CCTO) and directly supervises their assigned regulatory unit staff. The Regulatory Research Supervisor ensures regulatory compliance for clinical research studies, provides leadership and mentorship to regulatory personnel, and collaborates with investigators, sponsors, and research teams to support the timely and compliant conduct of clinical trials. The position also contributes to quality assurance, process improvement, and operational initiatives while serving as a regulatory subject matter expert within the CCTO.

Key Responsibilities

• Assures adherence within their regulatory unit to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies.
• Arranges orientation and provides training, supervision, and mentorship to their regulatory unit.
• Supervises vacation, out of office coverage, and time management of direct reports.
• Makes recommendations regarding regulatory personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions with guidance from Regulatory Manager.
• Monitors workload acuity with guidance from the Regulatory Manager.
• Assists regulatory specialists with technical issues, problem solving and intervention when appropriate.
• Ensures required timelines are met for submission, approval and distribution of protocol amendments, consent revisions and all applicable protocol specific documents for their regulatory unit.
• Assures compliance with OnCore entries ensuring that accuracy is maintained.