IRB Coordinator II

Saint Joseph Health

5d

About The Position

Responsible for the day to day operations and oversight of the Institutional Review Board. In conjunction with the Chairman, Conduct full IRB reviews (expedited/exempt). Independently manage investigator submissions Assist in SOP development and compliance review Liaison with investigators, sponsors, compliance officers. Support audit readiness, ensures hospital policies and procedures are maintained in compliance with the FDA, code of Federal Regulations, and Good Clinical Practice. Monitors the overall safety of the research patient, including HIPAA.

Requirements

• 2-4 years IRB or research compliance
• Bachelor's required

Nice To Haves

• CIP preferred (Certified IRB Professional)
• Master's preferred
• Eligibility for CIP preferred (Certified IRB Professional)

Responsibilities

• Day to day operations and oversight of the Institutional Review Board
• Conduct full IRB reviews (expedited/exempt)
• Independently manage investigator submissions
• Assist in SOP development and compliance review
• Liaison with investigators, sponsors, compliance officers
• Support audit readiness
• Ensures hospital policies and procedures are maintained in compliance with the FDA, code of Federal Regulations, and Good Clinical Practice
• Monitors the overall safety of the research patient, including HIPAA

What This Job Offers

• Job Type: Full-time
• Number of Employees: 5,001-10,000 employees