IRB Program Manager

Job Summary

Supervising the development and implementation of clinical research trials, the full-time IRB Program Manager will ensure compliance with IRB policies and federal regulations while providing guidance to investigators and coordinating resource utilization in a telecommuting environment.

Key responsibilities

• Coordinates review and approvals of research proposals to ensure compliance with all requirements
• Interacts with regulatory agencies and prepares for audits regarding research regulations
• Plans and implements training programs for IRB members and research staff on regulatory guidelines

Required qualifications

• Experience in clinical research and knowledge of IRB policies and procedures
• Understanding of federal regulations related to human subject research (OHRP and FDA)
• Proven ability to develop and implement training programs
• Strong organizational skills for managing IRB documentation and processes
• Experience in providing mentorship and oversight to research coordinators