IRB Program Manager

Position Details

Department: RSRCH-GRNT | Clinical Research Admin

Location: Telecommuting

Shift: Mon-Fri, Days, 8am-5pm

Category: Research

Posting #: 1055300

Employee Type: Full-Time

Position Summary

This position supervises the development, implementation, and evaluation of clinical research trials to ensure consistency with all IRB policies and procedures; coordinates resource requirement and utilization to ensure compliance with required federal, state, funding source, and all other applicable governing regulations, requirements, and standards. This position also provides regulatory, ethical and methodological guidance to investigators and coordinators to prepare applications for research proposals involving human subjects and provides consultation to IRB members and institutional officials regarding federal regulations and institutional policy.

Position Duties

• Coordinates review and approvals of research proposals by investigators through IRB and administrative procedures to ensure compliance with all requirements

• Interacts with the Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) and other governmental agencies regarding research regulations; prepares and participates (as necessary) in audits by the OHRP, FDA, or other governmental agencies

• Oversees day-to-day functions of the IRB, including pre-review of all IRB documents; generates and distributes IRB agendas, meeting packets, minutes, and correspondence in an accurate and timely manner

• Plans, develops and implements regulatory guideline training programs for physicians, coordinators and IRB members to ensure ongoing familiarity and understanding of applicable laws and requirements

• Plans, develops, implements, and evaluates all IRB department policies, procedures, and processes; implements quality assurance in conjunction with the Office of Research to ensure compliance with IRB standards and federal/state requirements

• Provides guidance to research investigators regarding FDA/OHRP requirements/regulations and IRB submission requirements

• Provides oversight and mentorship to the IRB Coordinator

• Reviews proposals and determines if they meet criteria for exemption under OHRP and FDA regulations

• Reviews proposals and determines if they meet the OHRP/FDA definition of Human Subject Research

• Reviews research study applications to ensure compliance with all federal, state, and regulatory agency requirements and specific institutional requirements; notifies appropriate individual of potentially serious adverse effects, non-compliance, and/or logistically difficult projects

• Performs miscellaneous job related duties as requested.