Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.
Clinical Research Protections provides administrative, regulatory, and operational support to the Cancer Protocol Review and Monitoring Committee (CPRMC), the Protocol Review and Monitoring Committee (PRMC), and the Institutional Review Board (IRB). 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. Accordingly, Research Protocol Analysts are familiar with 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 cancer center support grant requirements. Research Protocol Analysts also serve as resources familiar with appropriate regulations and requirements to COH researchers and committee members. Research Protocol Analysts have frequent interactions with Principal Investigators (PIs), study team members, committee members, and other departments involved in the review, approval and oversight of research conducted at City of Hope facilities or by its employees or agents.
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.
- Participate in quality improvement initiatives, including policy/procedure development, electronic form revisions, and workflow/dashboard enhancements.
- Participate in educational sessions for continuous learning.
Qualifications
Your qualifications should include:
- Bachelor's degree.
- At least 2 years of experience in the academic/clinical research review setting.
Preferred qualifications:
- Certified IRB Professional (CIP).
- Experience in review 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, please CLICK HERE.
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