IRB Analyst

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.

Specific
Duties & Responsibilities Include:

• 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.

See the Position Description for additional information.

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.

• 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

Only applications submitted through
the official UNMJobs site will be accepted. If you are viewing this job
advertisement on a 3rd party site, please
visit UNMJobs to submit an application.

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.