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

50% Supervisory - Training/Mentorship/Workload Management

• 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.

40% Leadership/Compliance/Process Improvement

• As part of the regulatory leadership team, collaborates with other Regulatory Supervisors and Regulatory Managers to identify team challenges, solutions, and improvement ideas.
• Develops a firm understanding of institution/department policies and guidance documents, recommending updates as applicable.
• Collaborates with Clinical Research Managers to ensure protocol amendments are processed in an efficient and timely manner.
• Works closely with Regulatory Manager and CCTO Project Manager(s) to ensure protocol opening timelines and protocol opening policies are met and followed.
• Actively participates in Regulatory team meetings and department meetings.
• Participates in external audits and internal process improvement strategies to promote consistent best practices.
• Performs routine quality assurance audits on electronic regulatory binders within their regulatory unit as needed.

10% Regulatory Affairs Coordination and Coverage

• May serve as regulatory contact and carry a regulatory workload as needed for team coverage and understanding of regulatory tasks and job functions.
• Serves as back-up to staff absences, vacancies, within assigned regulatory unit or across regulatory team as needed.
• Serves as back-up to Regulatory Manager if needed.

Work Location

Hybrid – This is not a remote position. This offer is contingent upon you working full-time, hybrid, on the Anschutz Medical Campus. You may be eligible to work a hybrid schedule after six months of employment. This benefit must be approved by your supervisor. In the event of departmental workload increase or special projects, you may be asked to report full-time on site until project completion.