Job Description

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

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.

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 include (but are not limited to) the following areas: *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

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

Knowledge, Skills and Abilities

• Working knowledge of applicable federal regulations governing IRB, IACUC, RCOI, research integrity, and research security.
• Experience conducting audits, compliance reviews, or investigations.
• Demonstrated experience implementing and maintaining policies, as well as managing programs and training.
• Exceptionally strong analytical, organizational, communication skills (written, verbal, presentation skills) as well as strong interpersonal skills.
• Demonstrated ability to work independently with minimal oversight or direction.
• High level of maturity, diplomacy, integrity and strict confidentiality.
• Willingness and desire to partake in professional development opportunities.
• Ability to work across disciplines.

Preferred Qualifications

• The preferred candidate will possess the following additional qualifications
  • 4 years human subject research experience or 4 years in research compliance-related role.
  • Prior experience with critical thinking, project management, document management and client interactions; 5-7 years across all categories in hospital research setting, university, or clinical research operation.
  • Certifications such as:
  • Certified IRB Professional (CIP)
  • Certified Professional IACUC Administrator (CPIA)
  • Certified Research Administrator (CRA)
  • Certified in Healthcare Research Compliance (CHRC)
  • Familiarity with accreditation standards (e.g., AAHRPP, AAALAC).
  • Experience with international research compliance, research misconduct processes, or export control oversight.
  • Proficiency in using electronic research administration systems (e.g., IRBNet, GRAMS, CoreStream).

Job Duties

• Compliance Monitoring and Quality Assurance:
  • 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)).
  • Conduct routine post-approval monitoring and for-cause audits for research protocols, and addition to assisting in audits for animal research, implemented RCOI management plans, activities involving foreign collaborations, research security and research integrity risks.
  • For the HSC Human Research Protection Program, maintain a list of investigators/studies which have an active Corrective Action Plan in place (as a result of non-compliance from an audit, routine IRB review, or self-report) and follow-up with investigators/study teams to ensure plans are have been implemented accordingly - work with the IRB office to identify when adjustments to plans might be needed. o Also includes (but is not limited to): preparing audit reports for presentation/review at IRB meetings; following up with investigators regarding audit findings; maintaining documents for completing post-approval monitoring (such as monitoring tools and checklists), and updating documentation/SOPs as needed.
• Program Development and Quality Improvement:
  • Collaborate with ORC leads to evaluate and enhance policies, procedures, and SOPs across research compliance domains.
  • rack and analyze QA/QI findings, generate regular reports for leadership, and propose data-driven improvements to strengthen program efficiency, consistency, and regulatory alignment. o Support readiness for internal and external reviews, such as AAALAC and AAHRPP accreditations, USDA or OLAW inspections, and other federal audits, in addition to assisting with internal UNT System audits. o Collaborate with researchers, principal investigators, and study teams to identify areas for improvement and provide training or resources as needed.
• Education and Training:
  • 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.
  • Partner with other units (e.g., Sponsored Programs, Biosafety/Environmental Health and Safety, Lab Animal Medicine, IT/IT Compliance) to create integrated educational materials aligned with compliance risks. - (Essential)
• Policy Integration and Institutional Support:
  • Serve as a secondary liaison to institutional committees such as the IRB, IACUC, Committee for Research Integrity, RCOI Committee, and Institutional Biosafety Committee.
  • Facilitate cross-functional initiatives to enhance communication and coordination across compliance areas.
  • Stay abreast of emerging regulatory requirements and best practices in the research compliance field; provide strategic recommendations to leadership.
  • Assist the ORC AVP with maintaining consistent communications with the HSC Institutional Compliance office to ensure policies and procedures remain up-to-date.

Physical Requirements

• Communicating with others to exchange information.
• Sedentary work that primarily involves sitting/standing.

Environmental Hazards

• No adverse environmental conditions expected.

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

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, 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. UNT System Administration promptly investigates complaints of discrimination, harassment, and related retaliation and takes remedial action when appropriate. System Administration 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 a related investigation or proceeding.