Research Compliance QA/QI Manager

University of North Texas System•Fort Worth, TX

1d•Onsite

About The Position

The Office of Research Compliance (ORC) at the University of North Texas Health Science Center, within the Division of Research & Innovation (DRI), is seeking a Quality Assurance & Quality Improvement (QA/QI) Manager. This role supports institutional compliance with federal, state, and institutional regulations governing research. The manager will lead initiatives for continuous quality improvement across the department and the HSC research community, fostering a culture of research excellence and accountability. Responsibilities include overseeing compliance audits, risk assessments, and process improvements, working closely with research teams, regulatory committees, and administrative departments.

Requirements

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

Nice To Haves

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).

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.
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 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.
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.
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.
Collaborate with researchers, principal investigators, and study teams to identify areas for improvement and provide training or resources as needed.
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.
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.