Research Protocol Analyst - Clinical Research Protections (Remote)

$72,051 - $111,696/Yr

City of Hope - Duarte, CA

Full-time - Mid Level

Remote - Duarte, CA

Hospitals

About the position

The Research Protocol Analyst at City of Hope plays a crucial role in managing human research protocols throughout their lifecycle, ensuring compliance with regulatory standards and facilitating the review process by various committees. This position involves collaboration with Principal Investigators and study teams to navigate the complexities of clinical research protections, ultimately contributing to the organization's mission of advancing cancer treatment and care.

Responsibilities

• Guide complex and standard protocols through scientific review and IRB 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.
• 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.
• Conduct quality control on informed consent documents for protocols submitted to external IRBs.
• Assist in developing annual IRB worksheets and supplemental materials as needed.
• Facilitate reliance agreements with partner organizations for ceded reviews.
• 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.

Requirements

• Bachelor's degree.
• At least 2 years of experience in the academic/clinical research review setting.

Nice-to-haves

• Certified IRB Professional (CIP).
• Experience in review and processing of research protocols in an academic research setting.

Benefits

• Comprehensive health insurance
• 401(k) retirement plan
• Paid time off
• Tuition reimbursement
• Employee assistance programs