IRB Specialist

Job Summary

A company is looking for an Institutional Review Board (IRB) Specialist.

Key Responsibilities

• Ensure efficient and consistent review of submitted research in compliance with federal regulations and institutional policies
• Maintain accurate records of IRB determinations and communicate effectively with research investigators and regulatory agencies
• Coordinate the research protocol submission process and provide education to IRB members and Clinical Research staff

Required Qualifications, Training, and Education

• Bachelor's degree or a minimum of six years of relevant work experience
• Completion of Collaborative Institutional Training Initiative (CITI) training and on-the-job (OTJ) training, including two years of IRB-specific training
• Knowledge of FDA and OHRP regulations and guidance documents
• Certified IRB Professional (CIP) certification is preferred