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EXEC DIR, IRB
Job Title: EXEC DIR, IRB
Job Code: 2923
FLSA: E
Job Level: 98
Revised Date: 02/01/2022
Job Family: JF 28
Occupational Summary
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).
Work Performed
Direct both the administrative and educational components of the IRB.
Act as the liaison between this group and the Chair/Vice Chair and the Senior IRB Chair in being responsible for all aspects of the DUHS IRB.
Direct the human subject 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 (6) Institutional Review Boards.
Coordinate problems, issues, and decisions with IRB leadership, staff, and board members, DUMC Compliance Office, the University Counsel's Office, Office of Science and Technology, and Risk Management Office.
Provide ultimate oversight of office personnel and HR issues, IRB budget, including fee collection, and the development of broad educational programs. Oversee development and implementation of automated compliance system (electronic (e)- IRB).
Provide review and approval of IRB submissions. Provide education and training about protection of human research subjects and IRB operations.
Oversee the process for obtaining accreditation by the Association of Accredited Human Research Protection Programs.
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.
Required Qualifications at this Level
Education/Training
M.A./M.S. degree in a related field.
Experience
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
Skills
N/A
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 University 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.
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Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job 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.