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, AAHRPP‑accredited 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:

• 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.
• Conducts for-cause and not-for-cause (routine) audits of human subjects research to assess compliance with federal regulations, institutional policies, and IRB determinations.
• 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.
• Prepares detailed reports and presents audit findings, noncompliance determinations, and unanticipated problems to Institutional Review Boards (IRBs) and institutional officials for review and action.
• Tracks and monitors corrective and preventive action plans (CAPAs), ensuring issues are appropriately resolved and documented in accordance with HRPP procedures.
• Provides guidance and support to investigators and research staff to promote compliance and facilitate the implementation of corrective actions and process improvements.
• Collaborates with HRPP staff to ensure consistent interpretation and application of federal regulations (45 CFR 46), institutional policies, and AAHRPP standards.
• Identifies trends, recurring issues, and areas of risk through QA/QI activities and communicates findings to HRPP leadership to inform program improvements.
• Assists in the development, implementation, and refinement of QA/QI processes, standard operating procedures (SOPs), and internal guidance documents.
• Contributes to ongoing efforts to maintain AAHRPP accreditation, including documentation, reporting, and continuous quality improvement initiatives.
• Supports training and education efforts related to research compliance, audit processes, and QA/QI best practices for HRPP staff and the research community.
• Participates in the development and monitoring of QA/QI performance metrics and reporting activities.
• May assist in coordinating QA/QI-related communications with institutional stakeholders and represent the HRPP in internal meetings as assigned.
• Performs miscellaneous duties as assigned.