This is a description of a Staff Position Classification. It is not an announcement of a position opening. To view descriptions of current openings, please go to UNMJobs and Search Postings to view positions that are currently accepting applications.
The following statements are intended to describe, in broad terms, the general functions and responsibility levels characteristic of positions assigned to this classification. They should not be viewed as an exhaustive list of the specific duties and prerequisites applicable to individual positions that have been so classified.
Summary
Analyzes and reviews human research protocol proposals and research records for completeness and compliance with regulations, Institutional Review Board (IRB) guidelines, and institutional policies. Identifies potential regulatory issues within proposals, and provides technical support, facilitation, procedural guidance, and procedural interaction with human research reviewers and investigators on regulatory and pre-review processing matters. Compiles and communicates documentation of Human Research Review Committee (HRRC) proceedings, including issues and determinations.
Duties and Responsibilities
Performs administrative analysis of protocol applications from researchers and of research records; reviews for completeness and compliance with appropriate regulations, IRB guidelines, and institutional policies.
Determines and recommends to reviewers the most expeditious allowable mechanisms for processing protocol applications.
Attends review committee meetings and provides technical support and guidance on regulatory matters; records medical and ethical issues discussed, and ensures accurate documentation of final committee determinations.
Composes clear, concise, and detailed correspondence to investigators to ensure that committee concerns, questions, and rationale are appropriately communicated to researchers; evaluates investigator's response to identify potential issues for research reviewers.
Assists researchers in the preparation of research compliance documentation and IRB responses; provides advice, guidance, and problem resolution to investigators and staff in the application of relevant Federal, State, and University laws, regulations, and guidelines.
Determines when IRB regulatory requirements for approval have been met, and issues approval documents.
Coordinates and monitors the collection, processing, and recording of protocol data, in accordance with established office procedures; maintains accurate IRB files in both electronic and hard-copy formats.
Provides day-to-day administrative collaboration and coordination between investigators, research staff, and research reviewers, as appropriate.
Assists in the preparation of review committee meeting agendas and materials.
May represent the IRB and the HRRC support office to various internal and/or external constituencies, as appropriate.
May oversee and guide the work of other support staff engaged in related activities.
Performs miscellaneous job-related duties as assigned.
Minimum Job 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.
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.
Highly developed analytical skills.
Skill in the use of personal computers and related software applications.
Records maintenance skills.
Knowledge and understanding of FDA and other Federal and State laws, regulations, guidelines, for the conduct, documentation, and reporting of human subject research.
Knowledge of procedures, parameters, and best practices in the processing of human research protocol applications and research records.
Ability to make administrative/procedural decisions and judgments.
Strong organizational skills and ability to manage multiple priorities in a high-volume environment.
Advanced technical writing and editorial skills.
Working Conditions and Physical Effort
No or very limited physical effort required.
No or very limited exposure to physical risk.
Work is normally performed in a typical interior/office work environment.
The University of New Mexico provides all training required by OSHA to ensure employee safety.
