Summary

Oversees, provides, and coordinates technical and administrative review of human research application materials prior to submission to the Institutional Review Board (IRB), providing support and guidance to investigators on content. Plans, organizes, and conducts audits of IRB-approved research to ensure compliance with all relevant laws, regulations, policies and guidelines, to protect human subjects, researchers, and the University, to assess clinical trial performance, and to discourage scientific misconduct in human subject research. Assists the IRB in planning and implenting training programs for faculty, staff, and administration in the conduct of biomedical research.

Duties and Responsibilities

1. Designs, develops, implements, evaluates, and modifies internal clinical research auditing programs, policies, protocols, procedures, systems, and documentation in accordance with Federal, State, and University mandates.
2. Organizes and performs random, for-cause, and IRB-requested audits of clinical research projects; reviews research and medical records and processes as appropriate to assess compliance with protocols and all Federal, State, and University requirements and guidelines.
3. Analyzes data and prepares and presents audit reports and summaries; provides feedback to researchers and the IRB as appropriate; ensures the maintenance of databases pertaining to human subject research audit information;.
4. Coordinates or oversees the review and processing of new research applications, progress of and changes to ongoing research, and adverse events.
5. Identifies educational needs of researchers based on audits and other information; designs, develops, presents, and evaluates targeted training programs and materials based on audit results and changes in legislative, statutory, and/or University requirement.
6. Provides advice, guidance, and problem resolution to research investigators and support personnel in the application of relevant Federal, State, and University laws, regulations, and guidelines.
7. Monitors the efficiency and accuracy of research investigators as part of the Federally mandated continuing review process.
8. Maintains a current knowledge of Federal, State, and University laws, regulations, and guidelines governing human subject research; attends educational and professional seminars as dictated by relevant certification standards.
9. Assists with specific inquiries related to scientific misconduct and/or IRB-related non-compliance issues, as requested.
10. Represents human subject compliance programs on various groups and committees, as appropriate; serves as institutional liaison to the Association of Clinical Research Professionals.
11. Manages day-to-day administrative operations of the program as assigned; may provide direct supervision to subordinate employees performing related work.
12. Undertakes special projects as assigned by the Dean of the School of Medicine and/or the Associate Dean of Research.
13. Performs miscellaneous job-related duties as assigned.

Minimum Job Requirements

• Bachelor's degree in Nursing, Biomedical Science, or closely related field; at least 3 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.
• 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 plan, organize, execute, and document comprehensive clinical research audits in compliance with federal and state requirements.
• Ability to make administrative/procedural decisions and judgments.
• Knowledge and understanding of the research continuing review process.
• 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.

Conditions of Employment

• For HSC positions: Certification as Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), or Certified IRB Professional (CIP) must be obtained within 1 year of date of hire.

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