Compliance Manager

University of North Texas System•Fort Worth, TX
•Onsite

About The Position

The University of North Texas Health Science Center (UNT Health), within the Division of Research & Innovation, is hiring an IRB Compliance Manager for the Office of Research Compliance and the North Texas Regional Institutional Review Board (NTR IRB). The role reports directly to the Director of the NTR IRB and works closely with the Office of Research Compliance, the IRB Committee, researchers, investigators, and partner organizations. The position supports human research protection across NTR IRB partners, including UNTHSC and John Peter Smith Health Network. It reviews biomedical, clinical trial, and social/behavioral research submissions for compliance with federal, state, local, and institutional requirements. The manager also supports IRB committee operations, researcher education, compliance training and outreach, accreditation efforts, special projects, and day-to-day IRB operations. The position is based in Fort Worth and is scheduled Monday through Friday, 8:00 a.m. to 5:00 p.m.

Requirements

  • Bachelor's degree and four years of related experience, or an equivalent combination of education and experience.
  • Thorough knowledge of appropriate federal regulatory agencies, including the FDA and OHRP.
  • Ability to develop and update websites, web pages, and online outreach and training tools.
  • Well-developed organizational and analytical skills, strong attention to detail, and ability to serve as an objective observer.
  • Strong written, verbal, and presentation skills.
  • Ability to collaborate and show initiative.
  • Professionalism, maturity, diplomacy, and ability to maintain strict confidentiality.

Nice To Haves

  • Bachelor's degree in a health sciences field; a master's degree is preferred.
  • Three years of human-subject research experience or three years in an IRB-related role.
  • Certified IRB Professional (CIP) certification or eligibility for certification.
  • Experience with critical thinking, project management, document management, and client interactions.
  • One to three years of experience across relevant areas in a hospital research setting, university, or clinical research operation.
  • Education and training experience in higher education.

Responsibilities

  • Assist the NTR IRB Director with daily IRB operations and development and implementation of human research protections for NTR IRB partners.
  • Conduct comprehensive administrative and regulatory reviews of new and continuing IRB submissions, amendments, reportable events, and other submissions to ensure compliance with applicable federal, state, local, and institutional requirements.
  • Provide education-based guidance and feedback to researchers and investigators regarding human-subject research policies and regulations, and assist with ongoing education and training.
  • Prepare submission documents, comments, and pre-review notes for IRB Committee review, and follow up with researchers on information needed before meetings.
  • Assist with oversight, attendance, and coordination of IRB Committee meetings, including preparing agendas, arranging meetings, tracking attendance and quorum, drafting and finalizing minutes, and communicating outcomes to investigators and institutional officials.
  • Assist with developing and delivering compliance training programs, workshops, seminars, guidance documents, training materials, videos, manuals, presentations, and other outreach tools.
  • Keep information on the NTR IRB website appropriately updated.
  • Assist with NTR IRB accreditation efforts, special projects, and ongoing operations.
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