IRB Reliance & Education Programs Manager

Jobtailor; New York (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Creighton University is seeking a senior regulatory professional to oversee IRB reliance policies, ensure compliance with educational and operational standards, and manage reliance agreements with external entities.

The role requires strong knowledge of 45 CFR 46 and FDA regulations, experience with sIRB workflows, and proven ability to develop training for IRB members and researchers. Excellent communication and documentation skills are essential.

Qualifications

• Bachelor's degree required; Master's or JD preferred in research compliance, public health, law, or related field.
• 4+ years of direct experience in Human Research Protection Programs or related regulatory field.
• Strong understanding of federal regulations and ethical principles governing human subjects research (45 CFR 46, FDA).
• Experience with sIRB reliance workflows preferred.
• Experience presenting education to diverse audiences.

Responsibilities

• Oversee the implementation and management of IRB reliance policies.
• Ensure regulatory compliance with reliance agreements between Creighton University and external entities.
• Lead the negotiation and execution of reliance agreements.
• Serve as the primary contact for external parties in reliance processes.
• Analyze and assess reliance studies and manage amendments.
• Develop and lead educational offerings for IRB members and researchers.
• Maintain a comprehensive database for all reliance agreements.
• Monitor the effectiveness of reliance processes and implement improvements.
• Provide regulatory support and consultative assistance to investigators.

Skills

IRB reliance policies

Analytical problem solving

Electronic IRB systems

Education

Bachelor's degree in a relevant field

Master's degree or JD preferred

Tools

Electronic IRB Systems

Job description

Creighton University is seeking a senior regulatory professional to oversee IRB reliance policies, ensure compliance with educational and operational standards, and manage reliance agreements with external entities.

The role requires strong knowledge of 45 CFR 46 and FDA regulations, experience with sIRB workflows, and proven ability to develop training for IRB members and researchers. Excellent communication and documentation skills are essential.