Institutional Review Board Compliance Manager

About the position The Office of Research Compliance (ORC) at the University of North Texas Health Science Center, in conjunction with the North Texas Regional Institutional Review Board (NTR IRB), is seeking to hire an IRB Compliance Manager to join our team. This position will report directly to the Director of the NTR IRB and will also work closely with the ORC. Responsibilities include (but are not limited to) the following 1) Assist with development and implementation of human research protection for all NTR IRB partners; 2) Perform comprehensive administrative and regulatory reviews of designated IRB submissions (which include biomedical, clinical trial, and social/behavioral science studies) by ensuring applications/submissions meet all federal agency regulatory requirements for human subject research; 3) Assist with ongoing education and training for all affiliated researchers to ensure appropriate compliance with federal, state and university/institutional policies and regulations associated with human subject research; 4) Prepare documents for review by the IRB reviewers/committee; 5) Assist with oversight, attendance and coordination of IRB committee meetings and communicate outcomes to investigators, relevant institutional officials, and federal agencies (when needed); 6) Assist with development and roll out of inhouse compliance training programs, workshops, seminars, guidance documents and other outreach and educational tools and training related to IRB and human subject research; 7) Assist in the daily activities, accreditation efforts, special projects and operation of the NTR IRB.

Responsibilities

• Assist NTR IRB Director with daily IRB operations, which includes development and implementation of human research protection for all NTR IRB partners (including but not necessarily limited to researchers from UNTHSC, John Peter Smith Health Network and other partners). This position will work directly with researchers/investigators from all organizations (as needed), and will also work closely with the IRB Committee (Chair and Board members) and fellow IRB Compliance Managers.
• Perform comprehensive administrative and regulatory reviews of designated IRB submissions (which include biomedical, clinical trial and social/behavioral science studies) by ensuring applications/submissions meet all federal agency regulatory requirements (e.g., Office for Human Research Protections OHRP; Food and Drug Administration FDA) for human subject research. This includes review of new submissions, in addition to continuing reviews, amendments, reportable events, etc. Additionally, this position will also ensure all institutional policies/procedures regarding human subject research are met, in addition to any other state and local regulations/policies.
• Assist with ongoing education and training for all researchers/investigators to ensure appropriate compliance with federal, state, and university/institutional policies and regulations associated with human subject research. This includes providing thorough, clear and detailed (education-based) guidance or feedback to researchers/investigators/NTR IRB partners regarding these matters. To this aim, the incumbent is expected to be knowledgeable and stay up-to-date regarding federal, state, and local/institutional regulations/policies/guidance.
• Prepare documents for review by the IRB Committee. This may include (but are not limited to) preparation of comments and pre-review notes for Board Member review, in addition to following up with researchers/investigators on information needed in preparation of discussion at IRB meetings.
• Assist with oversight, attendance and coordination of IRB committee meetings and communicate outcomes to investigators and relevant institutional officials. This also includes (but not be limited to) preparing meeting agendas, setting up/arranging the IRB meetings, tracking attendance/quorum during meetings, and drafting/finalizing detailed meeting minutes (which adhere to all federal regulatory requirements).
• Assist the NTR IRB Director, in addition to the ORC Executive Director, Education Outreach Coordinator and other research supporting units, with development and roll out of in-house compliance training programs, workshops, seminars, guidance documents and other outreach and educational tools and training related to IRB and human subject research. This may include preparation of educational/training documents, training videos, procedure and guidance manuals, or presentations to researchers/investigators, other key stakeholders or NTR IRB partners/clients. Additionally, assist in keeping information on the NTR IRB website appropriately updated.

Requirements

• Bachelor's degree and four (4) years related experience; or equivalent combination of education and experience.
• Thorough knowledge of appropriate federal regulatory agencies (FDA, OHRP)
• Skill set in development and update of web sites, web pages and online outreach and training tools
• Well-developed organizational and analytical skills; outstanding attention to detail; and objective observer
• Exceptionally strong written, verbal, and presentation skills; education and training experience in higher education preferred
• Highly collaborative and shows initiative
• High level of professionalism, maturity, diplomacy, and strict confidentiality Nice-to-haves
• Bachelors degree in any health sciences field, Masters Degree preferred
• 3 years human subject research experience or 3 years in an IRB-related role
• Certified IRB Professional (CIP) Certification or eligibility for such certification
• Prior experience with critical thinking, project management, document management and client interactions
• 1-3 years across all categories in hospital research setting, university, or clinical research operation Benefits
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