Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.

Clinical Research Protections (CRP) is in search of a Senior Research Protocol analyst to provide administrative, regulatory and operational support to the scientific review committees (Cancer Protocol Review and Monitoring Committee (CPRMC), Protocol Review and Monitoring Committee (PRMC), Biospecimen & Data Review Committee (BDRC)) and the Institutional Review Board (IRB). Senior Research Protocol Analysts manage a portfolio of human research protocols from initial submission through the protocol’s life cycle ensuring that protocols are reviewed appropriately by relevant committees. Senior Research Protocol Analysts are subject matter experts in the human subject protection regulations set forth at 45 CFR 46 and 21 CFR Parts 50, 56, 312, 600 and 812 and other federal guidance, as well as the NCI Cancer Center Support Grant requirements. Senior Research Protocol Analysts serve as the primary point of contact for issue resolution with Principal Investigators (PIs), study team members, committee members, and other Research Operations and City of Hope departments involved in the review, approval and oversight of research conducted at City of Hope facilities or by its employees or agents. Senior Research Protocol Analysts may also serve as COH IRB members and conduct reviews of submissions.

As a successful candidate you will:

Protocol Management:

• Guide complex and standard protocols through scientific review and IRB (internal/external) approvals, ensuring timely compliance with regulations.
• Pre-review submissions for completeness and adherence to IRB/committee policies and federal requirements.
• Collaborate with coordinators to assign expert reviewers and prepare comprehensive committee documentation.
• Liaise with investigators throughout the review process to address issues and ensure timely responses.

Committee Meetings:

• Prepare complete meeting materials for assigned protocols, including relevant reports (e.g., SAE and Deviations).
• Provide committee members with reference and guidance for new regulatory questions arising during meetings.
• Demonstrate thorough understanding of assigned protocols to answer committee inquiries about past reviews and overall history.

External IRB:

• Conduct quality control on informed consent documents for protocols submitted to external IRBs (e.g., NCI CIRB, NMDP sIRB).
• Assist in developing annual IRB worksheets and supplemental materials as needed.
• Facilitate reliance agreements with partner organizations for ceded reviews.

Quality Improvement and Training:

• Identify process improvements and efficiencies that enhance regulatory compliance and internal QC/QA programs.
• Stay up to date on regulations and guidance, and assist with training staff on relevant processes.
• Support the CRP Manager in quality improvement initiatives, including policy/procedure development, electronic form revisions, and workflow/dashboard enhancements.
• Participate in educational sessions for continuous learning.

Your qualifications should include:

• Bachelor’s degree.
• Experience may substitute for minimum education requirements.
• At least 5 years of experience in the academic/clinical research review setting.

Preferred qualifications:

• Master’s degree.
• Certified IRB Professional (CIP).
• Experience in reviewing and processing of research protocols in an academic research setting.

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity and inclusion, please click here.

To learn more about our Comprehensive Benefits, pleaseCLICK HERE.