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About the Role

The Program Manager, HRPP Regulatory Operations will execute education program activities, conduct pre-submission intake reviews, and provide IRB review and quality assurance support for the Human Research Protection Program (HRPP) at Saint Louis University. This role focuses on continuous improvement in human subjects research education and supporting institutional initiatives for AAHRPP accreditation.

Responsibilities

• Execute and evaluate the education program to ensure research compliance with regulations, laws, and policies.
• Monitor changes in regulations and technology, communicating potential operational impacts.
• Identify gaps in researcher education and training, developing resources and guidance.
• Maintain and track education program records for audits.
• Review and process incoming submissions, verifying compliance and routing to ancillary groups.
• Conduct structured pre-submission intake reviews to provide early feedback to investigators.
• Use intake review trends to inform the development of guidance, training, and educational resources.
• Review post-approval submissions and process human subjects research applications.
• Conduct protocol review across all submission types to support IRB review activities.
• Serve as a Designated Reviewer when appointed by the IRB Chair.
• Assist with quality assurance activities, including PI quality assurance reviews, audits, and CAPA development.
• Coordinate Institutional Review Board meetings and other meetings.
• Document review determinations and maintain committee rosters.
• Facilitate quality assurance review and research monitoring program visits.
• Process pre- and post-QAR visit documentation and reports.
• Facilitate the execution and maintenance of HRPP-related agreements.
• Develop and deliver training and seminars on research issues, submission requirements, and regulatory compliance.
• Develop and deliver targeted educational sessions addressing common submission deficiencies.
• Organize and implement continuing education initiatives for HRPP staff and board members.
• Identify educational needs across research departments.
• Contribute to efforts to attain and renew AAHRPP accreditation by developing required documentation.
• Develop and optimize HRPP forms, templates, workflows, and standard operating procedures.
• Coordinate the ongoing training and professional development of HRPP staff.
• Provide structured onboarding and competency training for new HRPP staff.
• Perform other duties as assigned.

Requirements

• Bachelor's degree.
• Three or more years of human subjects research experience with HRPP administrative functions.
• Five or more years of experience conducting, reviewing, and/or monitoring research involving human subjects, or equivalent combination of education and experience.
• Must be eligible for CIP (Certified IRB Professional) certification.

Skills

• Knowledge of ICH/GCP guidelines, FDA regulations, OHRP regulations, HIPAA Privacy Rule, and HRPP policies.
• Knowledge of medical and clinical terminology, research methodology and design.
• Strong analytical skills.
• Problem-solving skills within regulatory frameworks.
• Excellent verbal and written communication skills.
• Ability to work collaboratively and independently.
• Ability to maintain confidentiality.
• Ability to provide excellent customer service.
• Proficiency in personal computers, Microsoft Office products, and customized database software.
• Good organizational skills.
• Ability to work on multiple projects simultaneously.
• Flexibility and adaptability.
• Cooperative and positive attitude.

Location

• Saint Louis, MO

Work Type

• Full-time
• Onsite

Experience Level

• 3+ years of HRPP administrative experience
• 5+ years of human subjects research experience

Education Level

• Bachelor's degree
• Master's degree (preferred)
• CIP (Certified IRB Professional) (preferred)
• Relevant research-related quality assurance or clinical research certifications (preferred)

About the Company

• Founded in 1818, Saint Louis University is one of the nation’s oldest and most prestigious Catholic universities.
• SLU has a campus in Madrid, Spain.
• SLU is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.

Equal Opportunity

• Saint Louis University is an equal opportunity/affirmative action employer.
• All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors.
• If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.