Join the forefront of groundbreaking research 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. 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. A remote Research Protocol Analyst opportunity is available at City of Hope in the department of Clinical Research Protections. Research Protocol Analysts oversee human subject research protocols, ensuring compliance with federal regulations and cancer center grant requirements. They serve as resources for City of Hope researchers and committee members, interacting regularly with Principal Investigators, study teams, and other departments involved in research at City of Hope facilities. In this dynamic environment, their dedication ensures that every research protocol is executed with precision, integrity, and utmost ethical consideration. As a successful candidate, you will:
Protocol Management:

• Manage the full lifecycle of research protocol review-pre-reviewing submissions, coordinating expert committee evaluations, preparing regulatory documentation, and ensuring timely, compliant investigator responses to achieve Protocol Review and Monitoring Committees (PRMCs), and Institutional Review Board (IRB) approval.

• Prepare complete meeting materials, provide regulatory guidance for complex submissions, and be fully knowledgeable about the ethical and regulatory requirements for conducting human subjects research to support and address committee questions during protocol reviews.
• Experience interpreting and applying federal regulations when reviewing research protocols (exempt, expedited, and full board). Strong attention to detail while managing complex and high volume of protocol review submissions.

• Support external IRB oversight by performing reviews of the informed consent language for locally required boilerplate, assisting with annual worksheets and supplemental materials, and providing needed information when external institutions request to cede review.

• Assist with preparation for internal and external audits and maintain audit - ready protocols with complete, current, and compliant documentation.

• Contribute to quality-improvement efforts by identifying process efficiencies, staying current with regulations, updating policies, procedures, workflows, and electronic forms, enhancing reporting tools, and participating in educational sessions.

• Bachelor's degree (3 additional years of experience plus the minimum experience requirement may substitute for minimum education).
• At least 2 years of experience in an IRB or Human Research Protection Program (HRPP) office, including review and processing of research submissions such as new studies, amendments, and continuing reviews in an academic medical center, research institution, or NCI-designated cancer center setting.

• Availability to work weekdays from 8:00 a.m. to 5:00 p.m. Pacific Time.
• Experience processing submissions in an electronic committee management system (e.g. iMedris/ IRIS, Cayuse, OnCore, eIRB).
• Certified IRB Professional (CIP), Certified IRB Management (CIM), or other equivalent research certification.