Indiana University is one of the top research universities in the world, with over $785 million in sponsored research last fiscal year. Growing transformative research and creativity, innovation, industry engagement, and commercialization are key goals in IU 2030: The Indiana University Strategic Plan. The AVP for Research Compliance is a member of the Vice President for Research's senior leadership cabinet, which includes the IU School of Medicine Executive Associate Dean of Research Affairs. Reporting to the Indiana University Vice President for Research, the Associate Vice President (AVP) for Research Compliance (ORC) oversees 6 primary compliance functions university-wide (see below). ORC ensures service provision, including oversight of research compliance management systems, on all IU campuses university-wide, including IU Bloomington, IU Indianapolis, the School of Medicine, and 5 regional campuses located in Gary, Kokomo, New Albany, Richmond, and South Bend. Department-Specific Responsibilities - Responsible for the infrastructure and procedures that enable researchers on all IU campuses to remain in compliance with all applicable state and federal laws, as well as university policies.
- Collaborates closely with research leadership at the School of Medicine, other IU Research senior leaders, other relevant leaders across the university, and with key external partners.
- Provides high-level oversight of administrative offices and committees hat review thousands of studies or cases per year, and ensures policies and processes reflect the current regulatory environment, including but not limited to ensuring preparation for regulatory changes.
- Ensures staff are knowledgeable, service-oriented, and appropriately resourced.
- Engages with internal and external partners and stakeholders and will work to steward collaborative relationships with the IU research community, federal agencies, and accreditation bodies.
- The AVP has 7 director-level direct reports. The ORC team includes approximately 70 Full-Time Employees and the following organizational divisions and associated functions, as well as oversight of compliance management systems.
- Ensures the rights, welfare, safety, and consent of people who act as subjects in research projects.
- Upholds requirements for using animals in research, testing, or teaching.
- Provides oversight for IU's Institutional Biosafety Committees to review each protocol to ensure research is conducted with attention to the safety of laboratory personnel, the environment in which the research is conducted, and the community at large.
- Ensures oversight and safe use of radiation and radioactive materials that are potentially hazardous to human health working in collaboration with colleagues in IU Environmental Health and Safety.
- Documents and mitigates real or perceived issues when outside financial interests may overlap or conflict with a researcher's activities.
- Promotes integrity in research through education and adjudicating and addressing research misconduct.
- Provides leadership and operational oversight and continuous improvement of institutional compliance.
- Oversees continual quality improvement for ORC functions, ensuring ongoing implementation of best practices, providing strategic and integrative leadership to all units of ORC. This includes guaranteeing that each function, and associated compliance management systems, are not only delivering required compliance infrastructure but have workflow and procedures, providing quality assurance of service provision, required documentation, and user satisfaction.
- Ensures ongoing, streamlined compliance support to meet the broad research needs of IU's faculty, research staff and administrative units to ensure compliance while maximizing use of available resources and advocating for additional resources if/when needed.
- Establishes an integrated culture of compliance within the University and with external partners and stakeholders.
- Works with researchers across IU to foster a culture of strict ethical conduct of research and strong institutional compliance, including representing IU in communications with federal agencies. These communications include but are not limited to: answering questions; drafting and finalizing reports as required; collaborating on developing corrective action plans if needed; and providing comments on regulatory matters when requested or appropriate.
- Fosters a positive working relationship with faculty to build a culture of support.
- Responsible for building strong relationships with the leadership of accreditation bodies, professional organizations, and academic organizations, nationally and internationally, and serves as a resource when called upon for presentations, advice, or consultation by such organizations.
- Collaborates closely with the IU School of Medicine, all members of the IU Research Senior Leadership Team and support the Vice President for Research, while working alongside IU shared services partners to meet Office of Research Compliance needs on behalf of the researchers served. IU shared service partners include finance, HR, IT and communications and marketing.
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