IRB Compliance Analyst
About The Position
The Compliance Analyst is responsible for Compliance functions in the Office of Human Research Ethics ( OHRE ), including (1) triage and review of Promptly Reportable Information ( PRI ), (2) conducting fact-finding to prepare information for the Institutional Review Board ( IRB ), evaluating Corrective and Preventative Action plans, (4) documenting decisions and controverted issues by the IRB , (5) collaborating with partner UNC offices that contribute to reviews of compliance events, (6) monitoring the execution of compliance-related tasks, and (7) independently compose memos and letters. The Compliance Analyst may also serve as primary or secondary reviewer and an alternate voting member for each of the IRBs. The Compliance Analyst will ensure appropriate execution of OHRE Standard Operating Procedures (SOPs) and contribute to continual improvements to Compliance-related guidance, participate in process improvement initiatives and represent the program in meetings and discussions. The person in this role will also serve as a subject matter expert on federal regulations and OHRE SOPs pertaining to Unanticipated Problems and Noncompliance for investigators, study teams, IRB Chairs and members, OHRE personnel, and other relevant UNC departments, offices, centers, and institutions. The Analyst will also be responsible for assigned aspects of the AAHRPP re-accreditation process.
Requirements
- The candidate must have the ability to exercise sound judgment and facilitate good and timely decisions that comport with the university objectives and federal regulations pertaining to human subjects research.
Nice To Haves
- The preferred applicant will have full knowledge of applicable federal regulations governing human subjects research (21 CFR 50 & 56; 45 CFR 46), including regulations pertaining to Unanticipated Problems Involving Subjects or Others, Serious and Continuing Noncompliance, and Suspensions and Terminations of Approval (45 CFR 46.108; 21 CFR 56.108),Good Clinical Practice, HIPAA Privacy Rule.
Responsibilities
- triage and review of Promptly Reportable Information ( PRI )
- conducting fact-finding to prepare information for the Institutional Review Board ( IRB )
- evaluating Corrective and Preventative Action plans
- documenting decisions and controverted issues by the IRB
- collaborating with partner UNC offices that contribute to reviews of compliance events
- monitoring the execution of compliance-related tasks
- independently compose memos and letters
- serve as primary or secondary reviewer and an alternate voting member for each of the IRBs
- ensure appropriate execution of OHRE Standard Operating Procedures (SOPs) and contribute to continual improvements to Compliance-related guidance
- participate in process improvement initiatives and represent the program in meetings and discussions
- serve as a subject matter expert on federal regulations and OHRE SOPs pertaining to Unanticipated Problems and Noncompliance for investigators, study teams, IRB Chairs and members, OHRE personnel, and other relevant UNC departments, offices, centers, and institutions
- responsible for assigned aspects of the AAHRPP re-accreditation process
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
