Director of Research Compliance

Vanderbilt University Medical Center•Nashville, TN

About The Position

Discover Vanderbilt University Medical Center : Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research. Organization: Compliance & Corp Integrity Job Summary: The Vanderbilt Health Executive Search Team is conducting a national search for a Director of Research Compliance. The Director of Research Compliance, in the Office of Compliance and Corporate Integrity, coordinates key elements of VUMC’s research compliance program and promotes ethical business practices and adherence to the VUMC Credo, our policies, and our expectations that everyone here does the right thing. The Director of Research Compliance coordinates the VUMC Research Compliance Committee, oversees assigned program elements, and develops risk mitigation strategies for biomedical research regulatory requirements. . Shift: First Shift (Days)

Requirements

Master's Degree and 5 years of experience
Certification in Healthcare Privacy Compliance (CHPC) - Healthcare Compliance Association (HCCA)

Nice To Haves

10 years of experience preferred.
Strong legal regulatory experience preferred.
Research integrity experience preferred.
Research regulatory compliance experience in Human Subject Protection programs, FDA, NIH, and IRBs strongly preferred.
Experience with financial conflicts of interest relating to research environments is strongly preferred.
Excellent interpersonal skills, with the ability to communicate effectively and concisely both verbally and in writing with individuals and groups at various levels and various disciplines preferred.
Academic Medical Center experience strongly preferred.

Responsibilities

Plan, organize, and lead OCCI’s research compliance program, including development and implementation of research compliance work plans, risk mitigation and monitoring strategies, policy development, specialized research education, and implementation of policies to govern effective research compliance.
Assist the Vice President and Chief Compliance Officer in developing and executing on OCCI’s work plan, governance reporting, program management, and other OCCI leadership duties.
Lead investigations into regulatory compliance concerns involving human or animal research; Observe and advise the work of VUMC’s Institutional Review Boards, Biosafety Committee, and Institutional Animal Care and Use Committee.
Coordinate activities of the VUMC Research Compliance Committee (RCC), in close collaboration with committee Chairs and key stakeholders.
Develop and track appropriate research compliance key performance indicators to drive informed monitoring and continuous program improvement.
Promote integrity and compliance through frequent interaction with key VUMC leaders, and through targeted communications, education, and training focused on prioritized topics.
Interpret rules and regulations critical to effective research compliance, including VUMC policies, the Common Rule, research security, Antikickback Statute, etc., in consultation with other VUMC subject matter experts.
Assist CCI, OCCI, and key VUMC leaders in supporting compliance needs related to research security, research integrity, Federal-Wide Assurance restrictions, and other prioritized risk areas.
Serve as OCCI’s coordinating lead with VUMC Research Enterprise Leadership, Human Research Protections and Institutional Review Boards, Privacy, the Office of Legal Affairs, Office of Sponsored Projects, Export Controls, Animal Research, and other assigned stakeholder departments; Engage routinely with other research leaders and scientists to build relationships, trust, and awareness throughout the VUMC research enterprise.
Serve as the primary institutional authority for engagement with NIH, FDA, OHRP, ORI, USDA, DoD, and other federal agencies, including leadership of responses to audits, investigations, enforcement actions, and corrective action plans.
Advise on regulations and risk topics across OCCI’s scope of work in consultation with other VUMC subject matter experts, including rules and requirements promulgated by the National Institutes of Health, National Science Foundation, U.S. Food and Drug Administration, U.S. Department of Defense, and other key funding sources.
Collaborate on OCCI’s research compliance monitoring probes from prioritization through execution and reporting, including to RCC, CCI, and related committees.