Program Manager, HRPP Regulatory Operations
Core
Execute education programs, conduct pre-submission intake reviews, and provide IRB review and quality assurance support for the Human Research Protection Program (HRPP).
Role type
Senior HRPP Program Manager (Regulatory Operations)
Builds
Institutional compliance for human subjects research, AAHRPP accreditation, and IRB operational workflows
Domain
Higher education + Human subjects research regulatory compliance
Deliverable
Dashboards & analysis | Client delivery | Infrastructure
Required skills
Human subjects research regulatory compliance, IRB protocol review, AAHRPP accreditation standards, ICH/GCP guidelines, FDA regulations, OHRP regulations, HIPAA Privacy Rule, research methodology, quality assurance audits, CAPA development, training program design, stakeholder coordination
Preferred skills
CIP (Certified IRB Professional) certification, CCRA, CCRP, Master's degree
Technologies
Microsoft Office, customized database software
Responsibilities
Execute and evaluate education programs for research compliance; conduct structured pre-submission intake reviews to provide feedback; review protocols and serve as a Designated Reviewer for IRB; coordinate IRB meetings and manage committee rosters; develop and deliver training on regulatory compliance; contribute to AAHRPP accreditation efforts; coordinate staff training and onboarding
Seniority
Senior, hands-on IC