PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
The IU Human Research Protection Program (HRPP) encompasses research on seven IU campuses as well as research conducted by IU affiliates, including major state and local health systems such as IU Health, the Veteran’s Administration Hospital, Regenstrief Institute, and Eskenazi Health. The IU HRPP receives administrative support from the Quality Improvement Office and the Human Subjects Office, which are comprised of professional and administrative staff located both in Indianapolis and Bloomington.
The University Director of the Indiana University Human Research Protection Program (HRPP) is responsible for the strategic direction and functions of the HRPP which is comprised of two units: Human Subjects Office (HSO) and Quality Improvement Office (QIO). The University Director reports directly to the Associate Vice President for Research Compliance http://researchcompliance.iu.edu/
HRPP programs for which the University Director has authority include Human Subjects Office operations and compliance, IRB function and compliance, Clinical Research Billing compliance, the NIH ClinicalTrials.gov compliance program, the Human Research Auditing program, FDA Investigational New Drug and Investigational Device Exemption quality oversight, Research Compliance Concerns and Complaints oversight, and the Continuous Quality Improvement program. The IU HRPP has international, national (federal), state, and local commitments and responsibilities in terms of oversight, regulations, ethical principles, education, liability, auditing activities and rights and welfare of people participating in IU research.
The University Director ensures the HRPP, including the QIO, HSO and the seven federally-registered Institutional Review Boards (IRBs) are appropriately resourced, and develops and manages strategic budgets accordingly. The University Director is responsible for determining the organizational design of the HRPP, and consequently analyzing the effectiveness of the design and establishing future direction with regard to alignment of policies and development efforts. This position is responsible for the University’s compliance with the HRPP’s commitments and responsibilities as they relate to IU research involving human participants.
As the IU HRPP is one of the largest and most complex HRPPs in the U.S., the University Director is expected to serve as a subject matter expert for national professional organizations and represent and advance IU at national research conferences and in national research forums.
Bachelor’s degree, plus 10 years of senior administrative experience in regulatory compliance and research with human subjects. Must have a minimum of 5 years management experience. Certified IRB Professional (CIP), Certified in Healthcare Research Compliance (CHRC), Certified Research Coordinator (CRC) or Certified Research Associate (CRA) certification is required.
Combinations of education and related experience may be considered.
Must have expert knowledge of federal regulations relevant to the conduct of research involving human participants, excellent written and oral communication skills as well as the ability to tactfully and respectfully deliver difficult or sensitive news and negotiate complex political situations. Must have the ability to independently manage complex University programs, to organize and prioritize tasks and projects, and to meet routine and pressure deadlines. Experience with administering and overseeing electronic data management systems, conducting research involving human subjects or familiarity with social science or other research paradigms and methodologies. Must have experience or familiarity with FDA compliance initiatives including IND/IDE and auditing practices. Familiarity with federal guidelines for healthcare billings associated with clinical research, Medicare Coverage Analysis and Separation of Allowable Costs.
Must have significant supervisory experience and experience with KC IRB electronic system or other comparable human subjects electronic system. Must have the ability to negotiate and exert influence in a complex political environment.
As Indiana’s premier urban public research university, IUPUI believes in the power of transformation. We are committed to providing educational opportunities that transform the lives of our students, our community, and the changing world around us.
It was this commitment that was behind the merger of the Indianapolis campuses and programs of Indiana University and Purdue University—some of whic...h are more than 100 years old—that won accreditation by the Higher Learning Commission in 1969, creating IUPUI.
And it’s what binds us together today. We’re now Indiana’s premier urban research university offering more than 350 undergraduate, graduate, and professional programs from Indiana University and Purdue University - the most comprehensive array of degree programs in the state. We have combined the best of what Purdue University and Indiana University have to offer.