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Position Classification Description

Position Class Code / Title: A7065 / Mgr,Research Protections Opns
Recruitment Tier: Tier 1
FLSA: Exempt
Grade: 14

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

Oversees the technical and administrative review and auditing functions. Provides professional direction and administrative oversight of program operations, and assists the Institutional Review Board (IRB) in planning and implementing education and training programs to guide faculty, staff, and administration.

Duties and Responsibilities

  1. Oversees the review of human research application materials being submitted to the IRB; provides technical and administrative guidance to investigators on content, ensuring compliance with University, state, and federal policies an regulations.
  2. Manages and coordinates the quality assurance program, which audits the activities of researchers for compliance with University, state, and federal policies and regulations.
  3. Oversees the supervision of personnel, which includes work allocation, training, promotion, enforcement of internal procedures and controls, and problem resolution; evaluates performance and makes recommendations for personnel actions; motivates employees to achieve peak productivity and performance.
  4. Designs, develops, implements, evaluates, and modifies technical and administrative IRB review processes and internal research auditing policies, protocols, systems, and procedures, in accordance with government and University mandates.
  5. Analyzes data and prepares and presents IRB audit reports and summaries, and provides feedback to researchers and the IRB as appropriate; oversees the development and maintenance of IRB review and audit databases.
  6. Identifies educational needs of researchers, based on audit data and other information; develops and delivers targeted training programs and materials based on IRB review and audit results, as well as on changes to legislative, statutory, and/or University requirements.
  7. 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.
  8. Monitors the efficiency and accuracy of research investigators as part of the Federally mandated continuing review process.
  9. 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.
  10. Assists with specific inquiries related to scientific misconduct and/or IRB-related non-compliance issues, as requested.
  11. Represents human subject compliance programs to various groups and committees, as appropriate; may serves as institutional liaison to the Association of Clinical Research Professionals.
  12. Performs miscellaneous job-related duties as assigned.

Minimum Job Requirements

  • Successful completion of at least 60 college-level credit hours; 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

  • 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.
  • Knowledge and understanding of FDA and other Federal and State laws, regulations, guidelines, for the conduct, documentation, and reporting of human subject research.
  • Skill in examining and re-engineering operations and procedures, formulating policy, and developing and implementing new strategies and procedures.
  • Skill in organizing resources and establishing priorities.
  • Knowledge and understanding of the research continuing review process.
  • Program development and management skills.
  • Ability to supervise and train employees, to include organizing, prioritizing, and scheduling work assignments.
  • Knowledge and understanding of research quality assurance principles, policies, and procedures.
  • Skill in the use of computerized systems and databases.
  • Ability to foster a cooperative work environment.
  • Strong interpersonal skills and the ability to work effectively with a wide range of constituencies in a diverse community.
  • Knowledge of the mandates, operations, and organization of an Institutional Review Board.
  • Knowledge of current and emerging developments and trends within area of expertise.
  • Employee development and performance management skills.
  • 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