CTSI Regulatory Manager
Clinical and Translational Science Institute (CTSI)
(Research Support Manager 2, 9354S2)
The Regulatory Manager will provide leadership for the CTSI Regulatory Service Group and provide guidance and oversight on Regulatory issues and compliance for the Academic Health Center (AHC) at the University of Minnesota. The Regulatory Manager will oversee all operations of the CTSI Regulatory Service Group, including the CTSI monitoring program, IND/IDE assistance, and ClinicalTrials.gov compliance and will lead the group to ensure that UMN clinical research is conducted following good clinical practices (GCP) and standard operating procedures (SOPs), and is compliant with FDA and IRB guidelines. The Regulatory Manager will represent Regulatory affairs for the Academic Health Center (AHC) and collaborate across the University of Minnesota departments, CTSI functions, Office of the Vice President of Research (OVPR), and external organizations in order to ensure appropriate regulatory oversight and compliance for University of Minnesota clinical and translational research.
Regulatory Service Group Management
Plan, develop, implement, and manage regulatory service operations and programs within CTSI to support investigators conducting clinical and translational research.
- Oversee and guide the regulatory function to ensure that CTSI is compliant with federal and local standards in all activities. Refine service offerings, policies, and procedures to ensure compliance, promote efficiency, enhance user satisfaction, and improve research quality. Maintain knowledge of the current regulatory environment. Update and inform the Regulatory Service Group work to comply with changes to regulations.
- Supervise the Regulatory Group including: IND/IDE and ClinicalTrials.gov Specialist, and Clinical Trial Monitors. Hire and onboard new employees; provide daily work direction; supervise work to ensure timely and quality deliverables; coach and develop staff.
- Develop, implement, and manage the CTSI monitoring program to ensure appropriate monitoring and oversight for any trial that is classified by the Human Research Protection Program (HRPP) as greater than minimal risk.
- Ensure the CTSI monitoring plan reflects the regulatory guidance/foundation for each item in the plan, and indicates applicability of each item to interventional drug, interventional device, or other interventional or observational element.
- Conduct internal quality assurance audits of the CTSI monitoring program. Utilize data obtained through audits to address gaps in the monitoring program. Develop and implement Corrective and Preventive Action Plans, ensuring appropriate and timely follow-up and completion.
- Oversee CTSI monitoring reports and systems. Oversee monitoring reports, monitoring visit and findings data capture, and analysis of trends. Ensure monitoring visit reports are issued timely and that findings are resolved in a timely fashion or are escalated as needed.
- Ensure that quality support is provided to Principal Investigators and Research Support/Regulatory staff, including: regulatory consulting, IND/IDEs, and ClinicalTrials.gov.
- Monitor CTSI Regulatory Service Group productivity, CTSI Regulatory Service utilization, and user satisfaction with consultations/service offerings.
- Identify and resolve issues/concerns.
- Implement operational changes that better support staff as they work with investigators to initiate, execute, and complete projects/trials/studies.
Regulatory Environment/Quality Oversight
Represent clinical and translational research regulatory affairs for the Academic Health Center (AHC). Collaborate across the University of Minnesota departments, CTSI functions, Office of the Vice President of Research (OVPR), and external organizations in order to ensure appropriate regulatory oversight and compliance for University of Minnesota clinical and translational research.
- Review external monitor reports for University of Minnesota clinical research studies. Consolidate findings from both external monitoring and the CTSI internal monitoring program to identify common issues and opportunities to improve the conduct of research. Communicate insights to departments, IRB/HRPP, and domain experts. Work collaboratively to identify appropriate action plans to address common issues (e.g. training, policy changes, and procedures).
- Maintain knowledge of the current regulatory environment. Communicate regulatory changes and insights across the Academic Health Center and University, as appropriate.
- Work collaboratively with Workforce Development, HRPP, and departments to ensure that Researcher and Research Support/Regulatory Staff training, policies and procedures reflect current local and federal regulatory requirements and best practices.
- Work collaboratively with departments, CTSI functions, Office of the Vice President of Research and external organizations.
- Work with the Institutional Review Board (IRB) and the Office of the Vice President of Research (OVPR), who have final oversight for guidance and regulatory activities at the University, on behalf of the FDA and federal level research sponsors.
- Work with domain experts, departments, investigators, and departmental regulatory & research support staff to ensure CTSI Regulatory Service Group delivers high quality services, shares regulatory insights and improves regulatory quality.
- Represent University of Minnesota Regulatory affairs with external partners, including: Fairview Research Administration, Fairview Investigational Drug Services, FDA, external monitors/auditors, and research sponsors.
Other duties as assigned.
- BA/BS with 8 years of experience or an advanced degree with 6 years of experience, of which at least 4 years must include supervisory experience. Experience must be in a clinical research regulatory role or environment.
- Regulatory experience to include: managing regulatory aspects of clinical studies; proper filing and maintenance of investigator IND/IDE documents with the FDA
- Knowledge of compliance standards, e.g. informed consent process, adverse event reporting, the Federal Code of Regulations and Good Clinical Practice (GCP), ICH GCP, HIPAA regulations, and FDA regulations
- Ability to work with individuals at all levels of the institution/organization, including senior level administrators, faculty, and staff
- Demonstrated experience with public speaking
- Strong organizational skills and attention to detail, including evidence of ability to multi-task - Ability to understand and communicate clinical research protocol information
- Ability to work independently and collaboratively as part of a team
- Proficiency with Microsoft Office
- Advanced degree in health or biomedical discipline or public health
- Regulatory Affairs Certification (RAC)
- Experience with clinical trial monitoring
- Experience conducting GCP audits at clinical trial sites
- Previous Clinical Translational Science Award (CTSA) work experience
- Familiarity with academic medical centers
- Experience in developing a new program/service or expanding an existing program/service.