Director of Research Compliance

Discover Vanderbilt Health : With eight hospitals and over 180 clinics, we are the region’s largest comprehensive academic health system. Vanderbilt Health has a long tradition of providing world-class care to the people of the Mid-South, living out our mission of moving medicine forward through preeminent programs in patient care, education and research. Here you’ll find a spirit of collaboration and a supportive community where your expertise is valued, your knowledge expanded and your uniqueness celebrated. We are committed to fostering an environment where talented, compassionate people are united in bringing the most advanced care to our neighbors throughout the region.

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.

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Shift: First Shift (Days)

Role Accountabilities :

• •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.

Qualifications:

Master's Degree and 5 years of experience.

Preferred Qualifications:

• •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.

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Our professional administrative functions include critical supporting roles in information technology and informatics, finance, administration, legal and community affairs, human resources, communications and marketing, development, facilities, and many more.

At our growing health system, we support each other and encourage excellence among all who are part of our workforce. High-achieving employees stay at Vanderbilt Health for professional growth, appreciation of benefits, and a sense of community and purpose.

Core Accountabilities:

* Organizational Impact: Implements strategies for a sub function with direct impact to the function results.* Problem Solving/ Complexity of work: Resolves highly complex business issues that are often unprecedented that have immediate impact on own sub-function or entity and wider implications to the organization. * Breadth of Knowledge: Applies expertise within professional/technical area and uses advanced business knowledge to develop objectives.* Team Interaction: Leads a sub-function serving the organization at large or across one or more entity(s).

Core Capabilities :

Supporting Colleagues: - Develops Self and Others: Acts upon constructive feedback from all levels of the organization and initiates strategies to develop talent in others. - Builds and Maintains Relationships: Leverages relationships and insight to forecast potential future needs and influence delivery of work to exceed expectations. - Communicates Effectively: Anticipates difference audience concerns, styles and finds mutually beneficial solutions across conflicting and sensitive issues. Delivering Excellent Services: - Serves Others with Compassion: Demonstrates in-depth knowledge of broad-based issues and considers the interests of others to improve satisfaction of services. - Solves Complex Problems: Critically evaluates complex information and identifies trends/risks to make recommendations to improve processes across areas. - Offers Meaningful Advice and Support: Provides ongoing feedback and development discussions to motivate and support team members to maximize performance. Ensuring High Quality: - Performs Excellent Work: Anticipates problems or obstacles which may interfere with quality standards and develops plants to ensure area's quality standards are met. - Ensures Continuous Improvement: Routinely draws upon valuable learning from others, past experiences, and new information to determine key opportunities. - Fulfills Safety and Regulatory Requirements: Develops appropriate corrective actions for unsafe environments in order to ensure operational and safety compliance. Managing Resources Effectively: - Demonstrates Accountability: Identifies potential obstacles to goal achievement and develops solutions to address those obstacles. - Stewards Organizational Resources: Creates the appropriate systems and processes to effectively manage resources. - Makes Data Driven Decisions: Applies in-depth knowledge of data to recommend and implement new approaches to improve decision making capabilities. Fostering Innovation: - Genera