The Senior Research Compliance Consultant advises and consults with faculty, investigators/researchers and the Institutional Review Board (IRB) Committees on the submission, review and approval of complex human subject protocols. Provides regulatory, compliance, and ethics expertise to investigators involved in human subjects research. Provides compliance advice to IRB Committee members and external constituents. Serves as IRB member and issues approvals of University research on behalf of all campuses of the University. Assumes responsibility the following:
IRB Membership – Ensures the membership for all seven IRBs is compliant with federal and institutional regulations. Recruits faculty, physician, and non-affiliated members. Appoints IRB members in conjunction with the Vice President for Research. Periodically evaluates IRB members and adjust membership in consultation with Executive Leadership and IRB Chairs. Registers IRBs, IU, and Affiliate institutions with the federal government. Periodically evaluates the structure and function of the IRB convened committee process by evaluating metrics and benchmarks with industry leaders.
IRB Meetings – Oversees attendance requirements, manages research assignments to IRB members, consults and provides regulatory assistance to IRB members before and during the meeting, performs quality checks to ensure meeting agendas are accurate, assists Chairs with facilitation of meetings.
IRB Minutes – Ensures meeting minutes are executed accurately and in accordance with established timelines, performs quality checks of minutes to ensure regulatory criteria are satisfied.
Federal reporting – responsible for completing the required reports to federal agencies regarding IRB determinations, periodically trends reporting and scales issues up to management as needed, responds to queries from federal agencies.
REQUIRED: Bachelor's Degree in medical administration, social/behavioral sciences, education, health information or related field, plus 3 years of experience as a Research Compliance Consultant; 1 of those years as a Certified IRB Professional (CIP). Must have obtained CIP (Certified IRB Professional) certification.
Must have a comprehensive understanding of research requirements, policies and federal regulations. Must have the ability to understand, interpret, and apply complex federal, state, university and accreditation regulations pertaining to research involving human subjects.
Salary Plan: PAE
Salary Grade: 3AD
Campus: IUPUI - Indianapolis
Department: RESEARCH COMPLIANCE (UA-RCIN-IUINA)
Internal Number: 46739
About Indiana University
Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.