EXECUTIVE DIRECTOR, INST. REVIEW BOARD
School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Job Title: Executive Director, IRB
Leadership and responsibility for the oversight, administration, and coordination of policies and procedures related to the protection of the rights and welfare of human subjects in research and to ensure compliance with all federal, state, and local regulations and applicable institutional policies. Supervise both the administrative and educational components of the Institutional Review Board (IRB). Serve as an IRB Chairperson and oversee the DUHS IRB’s single/central IRB functions.
Direct both the administrative and educational components of the IRB office.
Act as the liaison between the IRB office personnel and the Chairs in being responsible for all aspects of the DUHS IRB.
Serve as an IRB Chair with regular co-Chair responsibilities during convened IRB meetings and the review of expedited and exempt submissions.
Direct the IRB component of Duke’s Human Research Protection Program.
Maintain and negotiate institutional assurances regarding human research subject protections.
Establish, evaluate, and oversee the administrative operations, policies and procedures of the (10) Institutional Review Boards.
Work closely with the Vice Dean/DUSOM leadership to identify and develop strategic initiatives within the DUHS IRB with subsequent oversight of those initiatives including, but not limited to, 1) creation and oversight of the DUHS IRB’s national single/central IRB program; 2) implementation of a new electronic IRB compliance system; 3) creation and implementation of a strategic review process for eConsent; and 4) creation of a career pathway for IRB members and staff.
Coordinate problems, issues, and decisions with the Vice Dean, IRB Chairs, staff, and board members, Duke’s Office of Audit, Risk and Compliance, the University Counsel’s Office, Office of Research Contracts, Duke Office of Clinical Research, and Duke’s Risk Management Office.
Oversee IRB personnel and HR issues, IRB Chairs, IRB budget, and the development of broad educational programs. Oversee the continuing development of the IRB’s current automated compliance system (electronic iRIS).
Provide education and training about protection of human research subjects and IRB operations to the Duke research community.
Oversee the process for maintaining accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Oversee Duke Health’s central IRB initiative.
Perform other related duties incidental to the work described herein.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Remote/Hybrid work arrangements are possible.
M.A./M.S. degree in a related field
Minimum of eight years of related experience in and a thorough knowledge of Institutional Review Board practices and relevant federal regulations and guidance is required. Experience as an IRB member is highly desired. Research and/or clinical experience is highly desired. Training in a medical or allied health field is desired. Administrative management (financial management and personnel management training and experience) is also desired. CIP or CIM certification is preferred. Other combination of relevant education and experience will be considered.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description
Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.