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Duke University Job Description: |
Job Title: ADMINISTRATOR, IRB |
Job Code: 2401 |
FLSA: E |
Job Level: 16 |
Revised Date: 06/16/2025 |
Job Family: JF 28 |
Manage the administrative and business processes of the Institutional Review Boards (IRB) in support of complex research protocols to include planning, interpreting, and coordinating procedural activities within the overall scope of relevant federal regulations for research involving human subjects at Duke University Medical Center.
Interpret institutional and federal policies, procedures, and regulations regarding Medical Center research studies involving human subjects;ensure updated policies, procedures, and federal guidelines are distributed as appropriate or posted on the IRB website; determine if proposed research projects are exempt or meet guidelines for expedited review.
Update Annual Multiple Project Assurance of Compliance with Department of Health and Human Services Regulations for Protection of Human Research Subjects; review and modify associated departmental and board procedures to ensure ongoing compliance; review updates and changes with Chairs of IRBs and appropriate senior Medical Center administrators and participate in the negotiation of Multiple Project Assurance document.
Manage review of protocol submissions for completeness of materials, adherence to institutional policies and procedures, and federal regulations; review informed consent documents for inclusion of all appropriate elements required by federal guidelines.
Recommend reviewers for proposed research projects to IRB Chairs; manage the process of research review to include ensuring all necessary information has been submitted to the IRB office and forwarded to the appropriate reviewer; manage the calendar and agenda for bi-monthly IRB meetings,ensuring appropriate reviewer summaries are distributed to board members before meetings.
Manage compilation of appropriate records and documentation on all research protocols involving human subjects.
Maintain liaison with departmental personnel involved in clinical research and research support; develop, conduct, and participate in training of principal investigators regarding applicable policies, procedures, and regulations.
Coordinate with the Director of the Office of Grants and Contracts on complex research projects involving other universities and research organizations to ensure issuance of necessary federally required documents, including, but not limited to, Single Project Assurances, Interinstitutional Agreements, and Cooperative Amendments.
Supervise the work of assigned personnel, reviewing completed work for adherence to institutional and federal guidelines.
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.
| Education/Training: | Work requires a Bachelor's degree in Business, Public Health, or a related field. |
| Experience: | Work requires seven years of clinical research experience managing research studies to include experience with internal and external review agencies, experience in regulatory oversight processes, including experience with review boards, or a combination of experience sufficient to analyze, understand, and interpret complex policies and federal regulations governing human subjects. A masters degree in Business Administration, Public Health, or a related field may be substituted for experience on a 1:1 basis. 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 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, (including pregnancy and pregnancy related conditions), sexual orientation, or military 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.
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.