Research Protocol Analyst (Remote) - Clinical Research Protections

Job Description - Research Protocol Analyst (Remote) - Clinical Research Protections (10030073) Job Description Research Protocol Analyst (Remote) - Clinical Research Protections - ( 10030073 ) Description 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. We are looking for a Research Protocol Analyst within the Clinical Research Protections department. They provide 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). You will 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. You must be 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. This position is fully remote. As a successful candidate you will: · Shepherd protocols through the C/PRMC and IRB review processes to achieve a timely outcome that is compliant with applicable regulations. · Manage new protocols, amendments, continuing reviews, deviations, unanticipated problems and other reportable events. · Prepare materials for committee meetings for assigned protocol submissions ensuring completeness and supplement the packets with relevant reports, e.g., SAE and Deviations reports. · As requested, assist in preparing materials for internal and external audits and accreditations and ensure assigned protocols are audit ready with appropriate documentation is filed, current and compliant with internal and external requirements. · Participate as requested in quality improvement initiatives which may include but are not limited to policy and/or procedure development or updates, electronic form revision in iRIS, workflow updates and report and dashboard enhancements to support daily operations. Qualifications Your qualifications should include: · A Bachelors degree with at least 2 years of experience in academic/clinical research review setting. At least 5 years of experience required to substitute for the minimum education requirement. · Experience in review and processing of research protocols in an academic research setting · Knowledge of complex federal and state regulations involving the use of human and/or animal subjects in research · Effective interpersonal skills to deal with complex, sensitive and confidential material with PIs and administrative and research personnel. · Certified IRB Professional (CIP) is preferred but not required · Software experience related to the role includes Microsoft Office; Outlook Excel; iMedRIS (Committee management software); Forte’s OnCore (clinical research management system) City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location. City of Hope is an equal opportunity employer. To learn more about our Comprehensive Benefits, please CLICK HERE . Primary Location : United States-California-Duarte Job : Clinical Research Work Force Type : Remote Shift : Days Job Posting : May 3, 2025 Minimum Hourly Rate ($) : 35.682500 Maximum Hourly Rate ($) : 55.307600