IRB Reliance and Education Manager

The IRB Reliance & Education Manager oversees the implementation and management of IRB reliance policies, procedures, and human subjects research education. This role ensures regulatory and institutional compliance with reliance agreements between Creighton University and external research entities, maintaining agreements that meet applicable regulations and guidelines.

Requires strong organizational, communication, and negotiation skills, along with a thorough understanding of IRB processes and regulations. Working independently, the manager escalates complex issues with recommended solutions to IRB leadership as appropriate, supports compliance and quality assurance activities.

Essential Functions:

• Lead and manage the negotiation, development, and execution of reliance agreements between Creighton University and external research entities for both reliance upon an external IRB and serving as the IRB of record. Ensure that Creighton University is complying with the responsibilities identified in reliance agreements (reporting, communications, etc).
• Serve as the primary point of contact for all external parties involved in the reliance agreement process. Determine the appropriate reliance pathway for multi-site studies (e.g., sIRB review, local IRB review). Work with IRB Director regarding complex matters that require additional leadership support or action.
• Responsible for the analysis and assessment of reliance studies (when CU is the slRB and when CU relies on a non-CU IRB) and studies reviewed by a commercial IRB. Manage amendments, renewals, and terminations of reliance agreements. Maintain updated policies, guidance, tools, and SOPs as related to IRB External research.
• Develop and lead educational offerings (CU IRB & Me sessions) for IRB members and Chairs, researchers, and the broader research community, including targeted training for department specific faculty, staff, and students participating in human subjects research. Provide ongoing education and training for all affiliated researchers to ensure appropriate compliance with federal, state and university/institutional policies and regulations associated with human subject research. Evaluate training effectiveness using participant feedback, performance indicators, and compliance trends; implement improvements as needed.
• Develop and maintain a comprehensive database and tracking system for all reliance agreements, including key terms, dates, and associated protocols. Create and provide reports to IRB Director regarding externally reviewed protocols. Ensure that all reliance agreements comply with institutional policies, as well as federal, state, and local regulations governing human subjects research. Evaluate reportable events submitted for ceded research and prepare recommendations for local institutional considerations to the IRB Director for discussion. Provide regulatory support for reporting sIRB related matters to regulatory agencies under the supervision of the IRB Director.
• Monitor the effectiveness and efficiency of reliance agreement processes and procedures. Identify areas for improvement and implement enhancements to streamline and optimize the reliance agreement process. Maintain expert knowledge of federal regulations (e.g., 45 CFR 46, FDA regulations), institutional policies, and best practices related to sIRB review and reliance.
• Serve as a designated IRB Reviewer for exempt, expedited, or full board submissions on an as needed basis. Provide assistance to IRB Director in preparation for AAHRPP accreditation and in various compliance and quality assurance activities (e.g. quarterly review of minutes, exempt/expedited review processes). Other duties as assigned.
• Provide consultative support to investigators and research teams regarding the establishment and maintenance of reliance agreements. Lead and manage the development and facilitation of training sessions and workshops to educate stakeholders about reliance/sIRB processes, procedures, and best practices, in collaboration with the IRB team (as needed). Represent the institution in reliance-related discussions and consortia (e.g., SMART IRB community).
• Conduct quarterly quality reviews of IRB minutes, reviews, and determination letters.

Qualifications:

• Bachelor's degree required, Master's or JD preferred, in a relevant field such as research compliance, public health, law, or a scientific discipline.
• 4+ years of direct experience in Human Research Protection Programs, research compliance, or a related regulatory field required.
• Strong understanding of federal regulations and ethical principles governing human subjects research (e.g., 45 CFR 46, FDA regulations).
• Experience with sIRB reliance workflows preferred.
• Building robust education programs is helpful.
• Experience presenting education to various audiences.
• Strong analytical and problem-solving abilities.
• Proficiency with electronic IRB systems.

Licenses/Certifications:

• Certified IRB Professional or the ability to obtain CIP credentials within 6 months of employment