IRB Analyst

University of New Mexico•Albuquerque, NM

10d•$20 - $27•Onsite

About The Position

The University of New Mexico Office of Research Integrity and Compliance (ORIC) is seeking a highly motivated, detail-oriented individual to join our Office of the Institutional Review Board (OIRB). The OIRB supports IRB members, faculty, staff and students in the administration of the human research protections program (HRPP) on UNM’s Central and Branch Campuses. The office promotes the safety and protection of individuals involved in human research by providing support, guidance, and education to facilitate ethical and scientifically sound research. The IRB Analyst will be primarily responsible for analyzing and reviewing human research proposals for completeness and compliance with federal regulations, IRB guidelines, and institutional policies.

Requirements

High school diploma or GED
At least 5 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.

Nice To Haves

Experience working with Institutional Review Boards and/or OHRP/FDA regulations regarding human subject research
Knowledge of federal regulations and guidance governing human subjects research, including 45 CFR 46 and HIPAA
Ability to recognize potential regulatory or institutional policy issues, apply established procedures and guidance, and seek assistance or escalate issues when additional review or guidance is needed.
Demonstrated organizational and time-management skills to process a heavy workload, under tight deadlines and conflicting priorities, while maintaining attention to detail
Demonstrated ability to work both independently and in a team-oriented environment, to follow through on assignments with minimal direction, and to independently prioritize work
Experience reviewing or analyzing complex information and applying established regulatory, policy, or procedural requirements to individual cases.
Effective written and oral communication skills and ability to use discretion and maintain confidentiality

Responsibilities

Performs administrative analysis of human research submissions to assess completeness, identify potential regulatory and institutional requirements, evaluate compliance with IRB policies and procedures, and identify issues requiring clarification or further review.
Applies established IRB procedures and guidance when reviewing submissions and consults with senior analysts or senior IRB staff when additional regulatory or policy guidance is needed.
Tracks submissions, requested revisions, investigator responses, and outstanding items to ensure timely processing and appropriate follow-up in accordance with established procedures.
Provides guidance and education to investigators, research staff, and students regarding IRB submission requirements and IRB procedures; assists researchers in resolving submission-related questions and deficiencies and consults with senior analysts or senior IRB staff when additional guidance is needed.
Prepares and issues IRB correspondence and approval documentation in accordance with established procedures.
Reviews investigator responses to IRB questions and requested revisions, evaluates whether requests have been adequately addressed.
Identifies any outstanding regulatory or institutional policy items needed based on guidance provided by senior IRB analysts.
Composes clear, concise, and detailed correspondence to investigators that clearly communicates committee concerns, questions, and the rationale for requested changes.
Assists with preparing meeting agendas, review materials, and related documentation for IRB review meetings; coordinates submission of materials and tracks items requiring follow-up.
Coordinates the collection, processing, and recording of IRB records, in accordance with established office procedures.
Ensures the accuracy and completeness of IRB records and electronic submission data; identifies and resolves discrepancies and maintains documentation in accordance with institutional recordkeeping requirements.