Project Manager, IRB Reliance & Cede Process Review

Job Title: Project Manager – IRB Reliance & Cede Process Review

Job Description

This role leads an independent, time‑bound review of Cede Application and Reliance Agreement processes within a high‑volume clinical research environment. You will evaluate the end‑to‑end cede workflow, identify operational risks and inefficiencies, and deliver clear, data‑driven recommendations that support leadership decision‑making and improve overall IRB reliance operations.

Responsibilities

• Lead and manage the full project over an anticipated 6–8 week timeline, ensuring milestones and deliverables are met on schedule.
• Plan, organize, and facilitate weekly meetings with HRPP leadership and key stakeholders to review progress, validate findings, and align on next steps.
• Conduct a comprehensive assessment of the Cede Application, including its content, structure, and usability, and recommend improvements.
• Review related instructions, education materials, policies, and workflows that support reliance and cede processes.
• Evaluate the end‑to‑end cede process from submission through agreement to cede, mapping current workflows and decision points.
• Identify operational risks, gaps, and inefficiencies within reliance and IRB review workflows, including areas that may delay review or create confusion.
• Conduct stakeholder interviews with HRPP leadership, IRB staff, research operations, and other institutional partners to understand current practices and pain points.
• Perform benchmarking against relevant best practices and peer institutions to inform recommendations.
• Develop detailed process maps that clearly depict current and proposed future‑state reliance and cede workflows.
• Prepare a comprehensive document review summary that synthesizes findings from policies, SOPs, education materials, and application content.
• Produce a structured findings and recommendations report that highlights key issues, proposed solutions, and expected impact on regulatory and operational performance.
• Create a practical implementation plan that outlines priorities, timelines, responsibilities, and change‑management considerations.
• Partner with Reliance and HRPP staff to support execution of approved changes and ensure alignment with institutional policies and federal regulations.
• Support revisions to the Cede Application to enhance clarity, usability, and alignment with reliance requirements.
• Contribute to the development and refinement of education materials, including portal content, checklists, standard operating procedures (SOPs), and other tools to guide users.
• Help outline reliance and IRB processes clearly for stakeholders, setting realistic expectations for timelines, roles, and responsibilities.
• Identify and recommend specific process revisions that can shorten review time while maintaining regulatory compliance and institutional standards.
• Assist with rolling out updated processes, including communication, training support, and documentation to facilitate adoption and sustainability.
• Provide leadership with data‑driven insights and concise summaries that support strategic decisions related to IRB reliance and cede processes.

Essential Skills

• Extensive experience as a Senior‑level IRB professional with deep familiarity in IRB reliance and cede processes.
• Demonstrated expertise in IRB reliance agreement workflows, including evaluation of cede applications, assessment of reliance appropriateness, coordination with reviewing IRBs, and alignment with institutional HRPP policies and federal regulations.
• Strong project management skills with a track record of independently leading time‑bound initiatives, managing timelines, and delivering defined outputs within 6–8 week windows or similar.
• Proven ability in process assessment and improvement, including evaluating end‑to‑end workflows, identifying operational risks and gaps, and developing actionable, data‑driven recommendations.
• In‑depth knowledge of IRB applications and IRB review workflows in a clinical research setting.
• Solid understanding of federal regulations and Good Clinical Practice (GCP) as they relate to IRB oversight, reliance models, and institutional compliance frameworks.
• Strong analytical skills with the ability to synthesize complex regulatory and operational information into clear findings and recommendations.
• Excellent written and verbal communication skills, including the ability to create clear documentation, reports, and education materials.
• Proven stakeholder engagement skills, with the ability to partner effectively with HRPP leadership, IRB staff, research operations, and other institutional stakeholders.
• Experience creating

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