Associate Vice President (AVP) for Research Compliance (ORC) (Res Compliance Sr. Executive) at Indiana University in Indianapolis, Indiana

Job Description:

Department



RESEARCH COMPLIANCE (UA-RCIN-IUBLA)



Department Information



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.



Job Summary



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.


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 that 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.

Qualifications



EDUCATION



Required

• Ph.D., M.D., JD degree, or other relevant terminal degree including Pharm.D.

WORK EXPERIENCE



Required

• Demonstrated national experience as a research compliance thought leader


• Demonstrated experience with faculty or scientist training and mentoring programs


• Prior experience as a director or senior-level compliance administrator at a major research university, and preferably one with a medical school

SKILLS



Required

• Strategic and operational accountability for institutional compliance, ensuring each Office for Research Compliance (ORC) unit operates with integrity and efficiency and has ongoing programs for quality review and improvement

Working Conditions / Demands



This role requires the ability to effectively communicate and to operate a computer and other standard office productivity equipment. The position involves sedentary work as well as periods of time moving around an office environment, the campus, and travel. The person in this role must be able to perform the essential functions with or without an accommodation



Additional Information



This is an open, national, and rolling search. Review of applications will begin immediately as they are received. Candidates meeting all the required qualifications may be contacted immediately for inquiry and interview.



Work Location



IUI Indianapolis Campus, IU Bloomington Campus


This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.



Benefits Overview



For full-time staff employees, Indiana University offers a wide array of benefits including:

• Multiple plan options for medical insurance


• Dental insurance


• Health Savings Account with generous IU contribution


• Life insurance, LTD, and AD&D options


• Base retirement plan contribution from IU, subject to vesting


• Additional supplemental retirement plan options


• Tuition benefit for IU classes


• 10 paid holidays per year


• Generous Paid Time Off


• Paid Parental Leave


• Employee Assistance Program (EAP)

Learn more about our benefits by reviewing our online Benefits Brochure.



Job Classification



Career Level: Senior Executive


FLSA: Exempt


Job Function: Research


Job Family: Research Compliance


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Posting Disclaimer



This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.


If you wish to include a cover letter, you may include it with your resume when uploading attachments.



Equal Employment Opportunity



Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University's Notice of Non-Discrimination here which includes contact information.



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