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
Provides and/or coordinates pre-review of complex, involved human research protocol submission materials for completeness and compliance with regulations, Institutional Review Board (IRB) guidelines, and institutional policies. Participates in the development and re-engineering of pre-review policies, procedures, and systems, and in the design and implementation of major projects and programs supporting HRRC activities. Provides integrated technical support and problem resolution to faculty with respect to potential regulatory issues within proposals. Guides and coordinates the activities of lower level analysts and/or administrative support staff, as appropriate.
Duties and Responsibilities
Provides and/or coordinates comprehensive technical and compliance pre-review of study submissions, as assigned.
Provides advice and guidance to research investigators and support personnel with respect to the preparation, protocol, and documentation necessary to ensure compliance with provisions pertaining to human subject protections in biomedical and clinical research.
Coordinates the review and resolution of problems and issues with related institutional faculty review committees, as appropriate.
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.
Coordinates or oversees correspondence with investigators with regards to committee questions and concerns; reviews and evaluates investigator response, taking action as appropriate; determines if or when IRB requirements have been met, and coordinates the issuance of approval documents.
Maintains up-to-date understanding of Federal, State, and University laws, regulations, and guidelines governing human subject research; attends educational and professional seminars as required to maintain currency in areas related to human subject research compliance.
Participates in the development and/or re-engineering of operating processes and systems designed to support regulatory compliance objectives; analyzes and prepares recommendations to management on specific policy issues, as appropriate.
Assists in the execution of of major audits of clinical research projects; reviews research and medical records and processes as appropriate to assess compliance with protocols, regulatory requirements, and guidelines.
Participates in the development, design, and delivery of training for researchers, HRRC members, and/or staff with regards to human subjects research regulations, policies, procedures, and documentation.
Provides training and day-to-day guidance and leadership to lower level analysts; trains and supervises technical and/or support staff, as appropriate.
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.
May represent the IRB and the HRRC support office to various internal and/or external constituencies, as appropriate.
Performs miscellaneous job-related duties as assigned.
Minimum Job Requirements
High school diploma or GED; at least 7 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
Records maintenance skills.
Skill in the use of personal computers and related software applications.
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.
Skill in examining and evaluating operations and developing and/or re-engineering operating strategies, systems, and procedures.
Ability to understand and interpret complex, involved human subjects biomedical research proposals.
Strong organizational skills and ability to manage multiple priorities in a high-volume environment.
Ability to lead and functionally supervise staff.
Advanced analytical, evaluative, and objective critical thinking skills.
Knowledge of the mandates, operations, and organization of an Institutional Review Board.
Knowledge of current and emerging legislative, policy, and operational issues and trends in the area of human subjects research compliance.
Ability to develop and present educational programs and/or workshops.
Advanced technical writing and editorial skills.
Strong interpersonal skills and the ability to effectively work with a wide range of individuals and constituencies in a diverse community.
Distinguishing Characteristics
Position requires: a) Coordination and comprehensive technical pre-review of human subject research submissions; b) direct coordination and interaction with related institutional faculty committees; c) participation in audits of clinical research projects and review of research and medical records and processes for IRB compliance: d) participation in the development and delivery of faculty and staff training on human subjects research compliance issues; e) analyzing policy-related issues, recommending new policies, systems, and procedures, and participating in the re-engineering of existing policies, systems, and procedures, and f) leadership and/or supervision of lower level technical and/or administrative support staff.
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.
