The University of New Mexico Office of Research and Compliance 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 Main 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 Human Protections Specialist will oversee, coordinate, and provide technical and administrative review of human research application materials upon submission to the Institutional Review Board (IRB). They will provide support and guidance to investigators on content. They will also manage the administration of the electronic submission system including creation of training materials. In collaboration with the IRB Sr. Operations Manager, they will plan, organize, and conduct monitoring of IRB-approved research to ensure compliance with all relevant laws, regulations, policies and guidelines, to protect human subjects, researchers, and the University. Additionally, they will assist the IRB in planning and implementing training programs for faculty, staff, and administration in the conduct of human research.

Specific Duties & Responsibilities Include:

• Manages day to day administration and oversight of electronic research administration system for the Office of Research Integrity and Compliance.
• Analyzesdataandpreparesandpresentsreportsandsummaries of performance metrics and quality assurance (QA) initiatives; ensures the maintenance of databases pertaining to human subject research review.
• Schedules and oversees monthly IRB meeting, conduct pre-reviews of full board submissions.
• Identifieseducationalneedsofresearchersbasedonauditsandotherinformation;designs,develops,presents, and evaluates targeted training programs and materials based on internal QA findings and changes in legislative, statutory, and/or University requirement.
• Providesadvice,guidance,andproblemresolutiontoresearchinvestigatorsandsupportpersonnelinthe application of relevant Federal, State, and University laws, regulations, and guidelines.
• MaintainsacurrentknowledgeofFederal,State,andUniversitylaws,regulations,andguidelinesgoverning humansubjectresearch;attendseducationalandprofessionalseminarsasdictatedbyrelevantcertification and accreditation standards.
• Assistswithspecificinquiriesrelatedtoscientificmisconductand/orIRB-relatednon-complianceissues,as requested.
• Indirect supervision of IRB Analysts including training, guidance and project planning.
• UndertakesspecialprojectsasassignedbytheDirector of the Office of Research Integrity and Compliance.
• Performs miscellaneous job-related duties as assigned.

Knowledge, Skills and Abilities Required:

• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Ability to communicate effectively, both orally and in writing.
• Ability to gather data, compile information, and prepare reports.
• Knowledge and understanding of FDA and other Federal and State laws, regulations, guidelines, for the conduct, documentation, and reporting of human subject research.
• Ability to make administrative/procedural decisions and judgments.
• Knowledge of current technological developments/trends in area of expertise.
• Knowledge of the mandates, operations, and organization of an Institutional Review Board.
• Skill in the use of computerized systems and databases.
• Knowledge of the principals, methods, and protocols of research and associated projects.
• Ability to perform training needs analyses and to design and develop education/training programs, workshops, and associated materials.