Institutional Review Board Compliance Manager

Title

Institutional Review Board Compliance Manager

Compliance Manager

University of North Texas
- Health Science Center

HSC-Div of Rsrch & Innovation

HSC-Div of Rsrch & Innovation

HSC-Rsrch Compliance-390000

Fort Worth

Commensurate With Experience

1.000000

TRS Eligible

Welcome to the University of North Texas System. The UNT System includes the University of North Texas in Denton and Frisco, the University of North Texas at Dallas and UNT Dallas College of Law, and University of North Texas Health Fort Worth. We are the only university system based exclusively in the robust Dallas-Fort Worth region. We are growing with the North Texas region, employing more than 14,000 employees, educating a record 49,000+ students across our system, and awarding nearly 12,000 degrees each year.

We are one team comprised of individuals who are committed to excellence, curiosity and innovation. We are transforming lives and creating economic opportunity through education. We champion a people-first values-based culture where We Care about each other and those we serve. We believe that we are Better Together because we foster an environment of respect, belonging, and access for all.

We demonstrate Courageous Integrity through setting exceptional standards and acting in the best interest of our communities. We are encouraged to Be Curious about opportunities for learning, creating, discovering, and innovating, and are encouraged to learn from failure. Show Your Fire by joining our team and exhibiting your passion and pride in your work as part of our UNT System team.

Learn more about the UNT System and how we live our values System.edu.

The Office of Research Compliance (ORC) at the University of North Texas Health Science Center is located within the Division of Research & Innovation (DRI). The ORC works with offices responsible for specific components of research compliance and university research oversight committees such as the Institutional Review Board, Institutional Biosafety, Institutional Animal Care and Use, Research Conflict of Interest committees and the Export Control/Research Security/International Compliance Office to ensure the responsible conduct of research and compliance with university policies and federal regulations related to research activity.

The office oversees development and implementation of policies, procedures, and educational activities which satisfy university policies, state, and federal regulations governing the conduct of research. The ORC is responsible for monitoring regulatory updates and making recommendations to the university to ensure compliance.

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.

Bachelor's degree and four (4) years related experience; or equivalent combination of education and experience.

• 1) Thorough knowledge of appropriate federal regulatory agencies (FDA, OHRP);
• 2) Skill set in development and update of web sites, web pages and online outreach and training tools;
• 3) Well-developed organizational and analytical skills; outstanding attention to detail; and objective observer;
• 4) Exceptionally strong written, verbal, and presentation skills; education and training experience in higher education preferred;
• 5) Highly collaborative and…