IRB & HRPP Operations Leader

Saint Louis University; St. Louis (MO); On-site; USD 70,000 - 100,000; Full time

Job summary

Saint Louis University seeks a Program Manager for HRPP Regulatory Operations to execute education programs, conduct intake reviews, and support IRB review and QA activities. The role emphasizes continuous improvement in human subjects research education and AAHRPP accreditation efforts.

The position involves developing guidance documents, training researchers, and coordinating HRPP staff activities to ensure compliance with applicable laws and policies.

Qualifications

• Knowledge of ICH/GCP, FDA and OHRP regulations relevant to HRPP activities.
• Strong analytical and problem-solving abilities for regulatory compliance.
• Excellent communication skills, both written and oral.
• Ability to work collaboratively and maintain confidentiality.

Responsibilities

• Execute education program activities and maintain training resources.
• Conduct pre-submission intake reviews and provide actionable feedback.
• Support IRB review processes and QA activities for studies.
• Coordinate IRB meetings and manage committee rosters.
• Develop training sessions and educational materials for researchers.
• Contribute to AAHRPP accreditation efforts and documentation.
• Oversee onboarding and professional development for HRPP staff.
• Perform other duties as assigned

Skills

ICH/GCP guidelines

FDA regulations

Analytical skills

Verbal & written communication

MS Office

Organizational skills

Team collaboration

Education

Bachelor's degree

Master's degree preferred

CIP eligibility

Tools

MS Office

Custom database software

Job description

Saint Louis University seeks a Program Manager for HRPP Regulatory Operations to execute education programs, conduct intake reviews, and support IRB review and QA activities. The role emphasizes continuous improvement in human subjects research education and AAHRPP accreditation efforts.

The position involves developing guidance documents, training researchers, and coordinating HRPP staff activities to ensure compliance with applicable laws and policies.