Summary

Coordinates and facilitates development and submission for formal internal review of applications for the conduct of biomedical and/or other federally regulated life sciences research studies, in accordance with all relevant Federal and State regulations and guidelines. Organizes and coordinates scientific review committee meetings and activities, reviews and screens new and/or modified research applications, and advises and educates committee members and research staff on compliance issues. Advises and assists researchers in the preparation and submission of protocols for compliance review. Assists in the development of protocol policies and procedures as appropriate. Establishes and maintains records and databases, in accordance with regulatory requirements.

Duties and Responsibilities

1. Reviews submissions of new research proposals, revisions and addenda, and other research documentation; advises investigators on revisions needed to comply with appropriate federal regulations and guidelines, state laws, and University policies and procedures.
2. Organizes, coordinates, and facilitates the meetings and associated activities of the applicable scientific review committee; determines and assigns discipline-specific proposals to appropriate committee members for review.
3. Oversees and coordinates the processing and maintenance of all research documents and records for the organization, ensuring compliance with all relevant Federal and State regulations and requirements.
4. Informs and advises committee members and researchers on applicable federal, state, and University regulations and guidelines governing the specific area of research; formulates and disseminates updates internal procedures and documentation in accordance with changes in compliance regulations and requirements.
5. Designs and implements fiscal, data management, and administrative systems, processes, and procedures consistent with the efficient day-to-day operation of the unit.
6. Maintains databases, researches information, compiles statistics, and gathers and computes various data as required; prepares special reports, summaries, and/or replies to inquiries.
7. Serves as a liaison with other operating units and a range of internal and external constituencies in the resolution of complex administrative and operational problems and issues.
8. Participates in preparing, and administering capital and operating budgets for the unit; performs routine expenditure analyses and prepares standard and specialized reports.
9. Supervises the work of other staff members as appropriate to the position, monitoring work assignments, and providing on-going staff training.
10. 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

• Ability to communicate effectively, both orally and in writing.
• Ability to work under pressure, to meet strict deadlines, and to meet production requirements within established quality standards.
• Demonstrated analytical and problem solving abilities, including skills in making recommendations and decisions.
• Strong interpersonal skills, flexibility, and customer service orientation.
• Skill in organizing resources and establishing priorities.
• Knowledge of federal, state, and local regulations, guidelines, and standards in area of expertise.
• Ability to make administrative/procedural decisions and judgments.
• Knowledge of the principles, procedures, and ethical considerations surrounding the conduct of biomedical and/or human research.
• Ability to independently gather data, compile information, and prepare reports.
• Ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments.
• Strong computer skills, to include database management, word processing, spreatsheeting, e-mail, and the internet.

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.

Revised Date: 03/20/2017