The University of North Carolina at Chapel Hill (UNC) seeks a high-energy, service-oriented leader for the position of Director of the Office of Human Research Ethics (OHRE http://research.unc.edu/offices/human-research-ethics/). The OHRE is responsible for ethical and regulatory oversight of all research at UNC that involves human subjects. The OHRE oversees the planning, direction, and execution of the Institutional Review Boards (IRBs) and all related activities, with responsibility for approximately 4,500 active protocols. The OHRE Director reports to the Associate Vice Chancellor for Research and is responsible for the day-to-day management of approximately 20 professional and administrative staff and an annual operating budget of nearly $2 million. UNC has maintained AAHRPP accreditation since 2009. UNC’s annual externally funded research portfolio stands just under $800 million, an amount that has doubled in the last decade. Major funding sources include the National Institute of Health (NIH) and the National Science Foundation (NSF). UNC is among the nation’s leading universities in NIH funding; our clinical and translational science institute, (https://tracs.unc.edu/ ) funded in 2008, provides regulatory and research ethics support. Research endeavors span a broad array of disciplines, and UNC continues to commit significant resources to building the scale and quality of its research enterprise. UNC represents a highly collaborative and international research environment. It is common for researchers from multiple University schools, departments, and units to collaborate on research grants, contracts, and studies, and the University also partners with a large and diverse group of outside organizations around the world. This approach reflects the University’s emphasis on interdisciplinary teaching and scholarship between and among the health, natural and social sciences, as well as the liberal arts and the humanities.
To fulfill the University’s obligations to promote the ethical conduct of research and protect the rights of human research subjects, the OHRE Director will 1) assure compliance with federal, state, and institutional regulations, guidelines, and policies; 2) provide ongoing education, training, and mentoring for investigators, IRB members and staff, and university officials; and 3) oversee the OHRE office and its six IRBs, including operating budgets, and hiring, evaluation, promotion, and development of professional staff.
- Interpret and apply federal, state, and local regulations, policies, and procedures related to human subjects research. - Work closely with senior administrators to ensure institutional compliance with the ethical and regulatory requirements for human subjects research, and understand the impact of any proposed regulatory changes on institutional policies pertaining to human subjects research. - Act as primary liaison with federal and state agencies on human research issues; consult with proponent agency staff as necessary regarding the interpretation and implementation of guidelines. - Consult with the UNC Office of University Counsel staff, department chairs, and principal investigators regarding how guidelines should be implemented. - Monitor IRB activities and programs; prepare an annual operating budget, and supervise OHRE staff; maintain institutional assurances, registration, and approvals needed for the conduct of human research. - Implement and oversee necessary standards to maintain full AAHRPP accreditation. - Develop and present educational programs and workshops for IRB members, faculty and staff on the protection of human research subjects; provide guidance and consultation to investigators and research staff. - Ensure that OHRE staff are fully trained, provides consistent, helpful, and professional advice, and conducts assessments in a timely fashion.
Minimum Requirements: - Bachelor’s degree with at least 10 years of experience in human subjects research, or a graduate degree with 5 years of experience in human subjects research. - Expected to obtain the Certified IRB Professional (CIP) certification upon eligibility if you have not already obtained the certification. Preferred Qualifications: - Minimum of a graduate degree is strongly preferred. - Certified IRB Professional (CIP) certification is highly desired.
Qualifications and Experience
The Director will be a well-respected leader in research administration who is able to work within the leadership matrix of UNC. She or he will be a strategic thinker, displaying a passion for research, and expressing a strong personal commitment to the mission and values of the University. The Director will have exceptional interpersonal skills, be able to manage complex professional relationships with an appreciation for the inherent tensions and interdependencies of research oversight and research missions, and be able to navigate hard decisions with diplomacy.
- Demonstrated understanding of and experience in the research environment of a major university/medical center and its education, public service, and patient-care missions. - At least 3 years of supervisory experience, including management and professional experience, education, business acumen, judgment, and integrity to train, manage, and develop staff in an effective and consistent manner, and to lead operations that serve participants in human research, investigators, administrators, and regulators and represent the best interests of human subjects, and the University. - Expert knowledge of federal, state, and local agency regulations associated with sustaining and enhancing a campus-wide program for human subject protection, and working knowledge of AAHRPP standards and requirements. - Outstanding verbal and written communication stills, including the ability to develop and present effective educational and training materials. - Experience as a university-level researcher is desired.
The OFFICE OF HUMAN RESEARCH ETHICS (OHRE) administers, supports and oversees the work of the Institutional Review Boards (IRBs) and all related activities at UNC-Chapel Hill. Any research project involving human subjects proposed by a member of the faculty, a post-doc, a staff member or a student at UNC-Chapel Hill must be reviewed and approved by an IRB before that research may begin, and before related grants may be funded. These IRBs are federally mandated review committees, operating under regulations promulgated by the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services (DHHS) and the U.S. Food and Drug Administration (FDA). The IRBs and OHRE are critical components of a program that serves to protect the rights and welfare of more than one million human research subjects who take part in more than 5000 different research projects each year at UNC-Chapel Hill. All components of this program, coordinated through the OHRE, must work together to ensure institutional compliance with ethical principles and regulatory requirements.
The OHRE was established in 2003, reporting to the Vice Chancellor for Research. It was created to ...centralize what had been a highly decentralized human research protection system, an action necessary to secure accreditation for the program. In 2006 the OHRE received full accreditation from the Association for the Accreditation of Human Research Protection Programs and has been fully accredited ever since.