Research Compliance QA / QI Manager

Title : Research Compliance QA / QI Manager

Employee Classification : Sr. 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 : TRS Eligible

About Us - Values Overview

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 the University of North Texas Health Science Center at 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 at www.UNTSystem.edu.

Department Summary

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.

Position Overview

The Office of Research Compliance (ORC, which includes the North Texas Regional Institutional Review Board [NTR IRB], the Institutional Animal Care and Use Committee [IACUC], Research Conflict of Interest Committee [RCOI], the Office of Research Security and International Compliance [ORSIC] and Research Integrity [RI]), is seeking to hire a Quality Assurance & Quality Improvement (QA / QI) Manager to join our team. This position will report directly to the Assistant Vice President for Research Compliance. The incumbent is responsible for planning, executing, and overseeing QA / QI activities that support institutional compliance with federal, state, and institutional regulations governing research, as well as lead initiatives aimed at continuous quality improvement for all areas of the department and the HSC research community, supporting a culture of research excellence and accountability. The QA / QI Manager will work closely with research teams, regulatory committees, and administrative departments to oversee compliance audits, risk assessments, and process improvements across research projects.

Responsibilities

• Complete routine post-approval monitoring visits / audits for research studies
• Implement Quality Improvement Initiatives
• Monitor implemented corrective action plans for human subjects research, provide reports on effectiveness and / or suggest necessary changes
• Complete monitoring and reporting activities for various quality improvement projects within the department (for IACUC, IRB, RCOI, ORSIC), identifying trends and areas for improvement
• Assist with accreditation efforts for both the animal care and use program (AAALAC) and the human research program (AAHRPP)
• Work closely with the ORC AVP on training, outreach, and communications to facilitate regulatory compliance, foster a culture of research integrity, promote responsible conduct of research initiatives, and provide regulatory expertise & guidance to support the HSC and NTR IRB research communities
• Stay updated on changes in regulations and standards related to research compliance and integrate them into organizational practices
• Prepare detailed reports on audit findings, quality improvement initiatives, and compliance status for leadership and stakeholders
• Lead initiatives to enhance the organization's research compliance framework and promote a culture of ethical research practices

Minimum Qualifications

Bachelors degree and five (5) years of relevant professional experience; or any equivalent combination of education and experience.

Knowledge, Skills and Abilities

Preferred Qualifications

Certified IRB Professional (CIP)

Job Duties

Develop and maintain in-depth knowledge of the federal regulatory framework governing human subjects research (45 CFR 46, 21 CFR 50 / 56, HIPAA), animal research (9 CFR, PHS Policy, Guide for the Care and Use of Laboratory Animals), research COI (42 CFR Part 50, Subpart F, and 45 CFR Part 94), research misconduct (42 CFR Part 93 (PHS research misconduct)).

Collaborate with ORC leads to evaluate and enhance policies, procedures, and SOPs across research compliance domains. Track and analyze QA / QI findings, generate regular reports for leadership, and propose data?driven improvements to strengthen program efficiency, consistency, and regulatory alignment.

Assist other ORC leaders with developing and delivering targeted education for faculty, staff, students, and research administrators on compliance?related topics, including IRB / IACUC procedures, COI disclosure obligations, responsible conduct of research (RCR), and international research considerations.

Serve as a secondary liaison to institutional committees such as the IRB, IACUC, Committee for Research Integrity, RCOI Committee, and Institutional Biosafety Committee.

Physical Requirements

Environmental Hazards

Work Schedule

Monday Friday, 8 am 5 pm

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

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.

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