Research Protocol Analyst - Clinical Research Protections (Remote)

$72,051 - $111,696/Yr

City of Hope - Duarte, CA

Full-time

Remote - Duarte, CA

Hospitals

About the position

The Research Protocol Analyst plays a crucial role in the Clinical Research Protections team, providing administrative, regulatory, and operational support to various committees overseeing human research protocols. This position ensures that protocols are reviewed and approved in compliance with federal regulations and institutional policies, facilitating the advancement of research aimed at combating serious illnesses such as cancer and diabetes.

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.
• Demonstrate thorough understanding of assigned protocols to answer committee inquiries about past reviews and overall history.
• 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.
• Participate in educational sessions for continuous learning.

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.