Compliance Manager, Healthcare

Title: Compliance Manager

Employee Classification: Compliance Manager

Campus: University of North Texas - Health Science Center

Division: HSC-Div of Rsrch & Innovation

Sub Division-Department: HSC-Div of Rsrch & Innovation

Department: HSC-Rsrch Compliance-390000

Job Location: Fort Worth

Salary: Commensurate With Experience

FTE: 1.000000

Retirement Eligibility: TRS Eligible

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.

• 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.

The preferred candidate will possess the following additional qualifications:

• 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.

• 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…