IRB COMPLIANCE SPECIALIST

OccupationalSummary

This po sition is responsible for assistingwith the development, implementation and management of the Duke UniversityHealth System (DUHS) institutional review board (IRB) compliance program. Attainand maintain comprehensive and up-to-date knowledge of human subject researchprotections and IRB re gulations as contained in 45 CFR 46, 21 CFR 50 & 52,and other applic able regulations. Create and revise departmental SOPs andpolicies. Serve as the subject matter expert on policies and regulations byproviding gu idance and training to researchers and staff, IRB members and IRBstaff a nd chairs. The IRB compliance specialist may also make regulatorydetermi nations as delegated by the IRB Executive Director.

WorkPerformed

Recruit, educate and train researchers and staff,IRB members and IRB personnel in the conduct of human subject research toen sure compliance with federal and state regulations and Duke Health syste mpolicies. Maintain credentials of IRBstaff and IRB member ship

Responsible for initial triaging of safety event ssubmitted in the IRB electronic system to IRB Chairs. May complete review of straightforward eventsubmissions.

Responsible for assigned aspects of the AAHRPP re-accreditationprocess< /span>

Maintenance of IRB rosters and submission of rosterst oOHRP

Maintain DUHS IRB Federal Wide Assurance (FWA)

Create letters required for external reporting togov ernment agencies

Responsible for review of minutes, f or regulatoryelements

Conduct internal QA/QI activiti es for the IRB

Review and process IRB submissionsfrom an assigned therapeutic area. Work may also involve reviewing andapprov ing minor amendments as determined by the Executive Director.

Review and analysis of submissionstotroubleshoot, maintain eff iciencies and report findings to the ExecutiveDirector.

Education

Work generally requires organizational, analytical and communication skills normally acquired through the completion of a bachelor's degree program. Master's degree preferred.

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

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.