Human Research Compliance & Quality Specialist

Position Summary:

The University of New Mexico Health Sciences (UNM HS) Office of Research is seeking an experienced and detail-oriented professional to serve as a Human Protections Specialist with primary responsibility for Quality Assurance and Quality Improvement (QA/QI) within the Human Research Protection Program (HRPP). This position supports the implementation and oversight of core QA/QI functions, including the review and evaluation of research compliance matters and the identification of process improvement opportunities across IRB operations.

Working closely with HRPP staff, investigators, and Institutional Review Boards (IRBs), the individual in this role applies federal regulations (45 CFR 46), institutional policies, and AAHRPP standards to promote consistent, thorough, and well-documented review processes. Through systematic assessment and communication of findings, this position contributes to the protection of human subjects and the integrity of the institution's research oversight activities.

The institution's Human Research Protections Program (HRPP) is a comprehensive, AAHRPPaccredited program dedicated to protecting the rights and welfare of individuals participating in human research. The Human Research Protections Office (HRPO) supports three Institutional Review Boards (IRBs), the Human Tissue Oversight Committee (HTOC), and the Scientific Review Committee (SRC) by providing regulatory oversight, guidance, and education. Through these activities, the HRPO promotes ethical, compliant, and scientifically sound human subjects research across the institution.

Specific Duties and Responsibilities include:

1. Coordinates and implements Quality Assurance and Quality Improvement (QA/QI) activities within the Human Research Protection Program (HRPP), with a focus on research compliance oversight and continuous improvement.
2. Conducts for-cause and not-for-cause (routine) audits of human subjects research to assess compliance with federal regulations, institutional policies, and IRB determinations.
3. Reviews and evaluates allegations and instances of noncompliance and unanticipated problems involving risks to participants or others (UPIRTSOs), ensuring thorough documentation, analysis, and appropriate follow-up.
4. Prepares detailed reports and presents audit findings, noncompliance determinations, and unanticipated problems to Institutional Review Boards (IRBs) and institutional officials for review and action.
5. Tracks and monitors corrective and preventive action plans (CAPAs), ensuring issues are appropriately resolved and documented in accordance with HRPP procedures.
6. Provides guidance and support to investigators and research staff to promote compliance and facilitate the implementation of corrective actions and process improvements.
7. Collaborates with HRPP staff to ensure consistent interpretation and application of federal regulations (45 CFR 46), institutional policies, and AAHRPP standards.
8. Identifies trends, recurring issues, and areas of risk through QA/QI activities and communicates findings to HRPP leadership to inform program improvements.
9. Assists in the development, implementation, and refinement of QA/QI processes, standard operating procedures (SOPs), and internal guidance documents.
10. Contributes to ongoing efforts to maintain AAHRPP accreditation, including documentation, reporting, and continuous quality improvement initiatives.
11. Supports training and education efforts related to research compliance, audit processes, and QA/QI best practices for HRPP staff and the research community.
12. Participates in the development and monitoring of QA/QI performance metrics and reporting activities.
13. May assist in coordinating QA/QI-related communications with institutional stakeholders and represent the HRPP in internal meetings as assigned.
14. Performs miscellaneous duties as assigned.

See the Position Description for additional information.

• For HSC positions: Certification as Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), or Certified IRB Professional (CIP) must be obtained within 1 year of date of hire.

Bachelor's degree in Nursing, Biomedical Science, or closely related field; at least 3 years of experience directly related to the duties and responsibilities specified.

Completed degree(s) from an accredited institution that are above the minimum education requirement may be substituted for experience on a year for year basis.

• Bachelor's degree in a relevant field (e.g., public health, clinical research, regulatory affairs, or related discipline).
• Demonstrated experience with increasing responsibility in a Human Research Protection Program (HRPP) or closely related compliance environment.
• Experience conducting or supporting research compliance audits, monitoring activities, or quality assurance/quality improvement (QA/QI) functions.
• Experience reviewing, analyzing, or supporting determinations related to noncompliance and unanticipated problems involving risks to participants or others (UPIRTSOs)
• Knowledge of federal regulations governing human subjects research, including 45 CFR 46, as well as AAHRPP accreditation standards.
• Knowledge of HIPAA Privacy Rule and applicable state laws governing the protection of personal health information.
• Experience working in an HRPP at a research university or academic medical center preferred.
• Experience preparing or reviewing materials submitted to an Institutional Review Board (IRB).
• Direct experience with IRB administration, research compliance, or human subjects research oversight.
• Experience using an electronic IRB system (e.g., Huron IRB); experience with Huron is preferred.
• Strong analytical, written, and verbal communication skills, including the ability to prepare clear summaries and present findings to IRBs or institutional stakeholders

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Positions posted with a Staff Type of Regular or Term are eligible for the Veteran Preference Program. See the Veteran Preference Program webpage for additional details.

The University of New Mexico is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability, or any other protected class.

The University of New Mexico requires all regular staff positions successfully pass a pre-employment background check. This may include, but is not limited to, a criminal history background check, New Mexico Department of Health fingerprint screening, New Mexico Children, Youth, and Families Department fingerprint screening, verification of education credentials, and/or verification of prior employment. For more information about background checks, visit https://policy.unm.edu/university-policies/3000/3280.html. Refer to https://policy.unm.edu/university-policies/3000/3200.html for a definition of Regular Staff.