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IRB COMPLIANCE SPECIALIST
Job Title: IRB COMPLIANCE SPECIALIST
Job Code: 3808
FLSA: E
Job Level: 14
Revised Date: 02/01/2022
Job Family: JF 28
Occupational Summary
This position is responsible for assisting with the development, implementation and management of the Duke University Health System (DUHS) institutional review board (IRB) compliance program. Attain and maintain comprehensive and up-to-date knowledge of human subject research protections and IRB regulations as contained in 45 CFR 46, 21 CFR 50 & 52, and other applicable regulations. Create and revise departmental SOPs and policies. Serve as the subject matter expert on policies and regulations by providing guidance and training to researchers and staff, IRB members and IRB staff and chairs. The IRB compliance specialist may also make regulatory determinations as delegated by the IRB Executive Director.
Work Performed
Recruit, educate and train researchers and staff, IRB members and IRB personnel in the conduct of human subject research to ensure compliance with federal and state regulations and Duke Health system policies.
Maintain credentials of IRB staff and IRB membership.
Responsible for initial triaging of safety events submitted in the IRB electronic system to IRB Chairs.
May complete review of straightforward event submissions.
Responsible for assigned aspects of the AAHRPP re-accreditation process Maintenance of IRB rosters and submission of rosters to OHRP.
Maintain DUHS IRB Federal Wide Assurance (FWA).
Create letters required for external reporting to government agencies Responsible for review of minutes, for regulatory elements.
Conduct internal QA/QI activities for the IRB.
Review and process IRB submissions from an assigned therapeutic area.
Work may also involve reviewing and approving minor amendments as determined by the Executive Director.
Review and analysis of submissions to troubleshoot, maintain efficiencies and report findings to the Executive Director.
Required Qualifications at this Level
Education/Training
Work generally requires organizational, analytical and communication skills normally acquired through the completion of a bachelor's degree program. Master's degree preferred.
Experience
Four years of knowledge of federal regulations governing clinical research and experience in a clinical/regulatory environment required.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Skills
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.
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 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.
