Compliance Manager

Title: Compliance Manager

Employee Classification: Compliance Manager

Campus: University of North Texas - Health Science Center

Division: HSC-Div of Rsrch & Innovation

SubDivision-Department: HSC-Div of Rsrch & Innovation

Department: HSC-Rsrch Compliance-390000

Job Location: Fort Worth

Salary: Commensurate With Experience

FTE: 1.000000

Retirement Eligibility:

About Us - Values Overview:

Department Summary

The Office of Research Compliance (ORC) at the University of North Texas Health Science Center is located within Research Administration and the Division of Research. 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 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.

Position Overview

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.

Minimum Qualifications

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

Knowledge, Skills and Abilities

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; objective observer; 4) Exceptionally strong written, verbal, and presentation skills; adult education and training experience (in higher education preferred); 5) Highly collaborative and shows initiative; 6) High level of professionalism, maturity, diplomacy, and strict confidentiality.

Preferred Qualifications

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.

Job Duties:

• 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 prereview 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) sending meeting invitation, preparing meeting agendas, setting up for IRB meetings, tracking and ensuring attendance/quorum prior to/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 and other research supporting units, with accreditation efforts as well as 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, human subject research, and Human Research Protection Program. This may include preparation of accreditation materials, 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.

Physical Requirements:

Communicating with others to exchange information.

Environmental Hazards:

No adverse environmental conditions expected.

Work Schedule:

M-F, 8 AM - 5 PM; eligible hybrid schedule

Driving University Vehicle:

No

Security Sensitive:

This is a Security Sensitive Position.

Special Instructions:

Applicants must submit a minimum of two professional references as part of their application. If needed, additional references can be added after the application has been submitted.

Benefits:

For information regarding our Benefits, click here.

EEO Statement:

The University of North Texas System is firmly committed to equal opportunity and does not permit -- and takes actions to prevent -- discrimination, harassment (including sexual violence, domestic violence, dating violence and stalking) and retaliation on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, or veteran status in its application, employment practices and facilities; nor permits race, color, national origin, religion, age, disability, veteran status, or sex discrimination and harassment in its admissions processes, and educational programs and activities, facilities and employment practices. The University of North Texas System promptly investigates complaints of discrimination, harassment and related retaliation and takes remedial action when appropriate. The University of North Texas System also takes actions to prevent retaliation against individuals who oppose any form of harassment or discriminatory practice, file a charge or report, or testify, assist or participate in an investigative proceeding or hearing.