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RESEARCH PROTOCOL ANALYST - DATA AND SAFETY MONITORING COMMITTEE - 10033526
Remote, USCity of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases.
Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a wholly owned subsidiary, was launched in 2019 and is dedicated to serving employers and their health care partners by providing access to City of Hope’s exceptional cancer expertise.
A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.
Join the forefront of groundbreaking research at the Beckman Research Institute of 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.
The department of Clinical Research Protections is looking for a Research Protocol Analyst who provides administrative, regulatory and operational support to the Data and Safety Monitoring Committee (DSMC). 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. Accordingly, you should 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. You will also have frequent interactions with Principal Investigators, 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:
· Shepherd protocols through the DSMC and IRB review processes to achieve a timely outcome that is compliant with applicable regulations.
· Be responsible for managing the review of new protocols, amendments, progress reports, monitoring reports, audits, serious adverse events (SAEs), 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 ready with appropriate documentation is filed, current and compliant with internal and external requirements.
· Identify areas for process improvement and efficiencies that also support regulatory compliance.
· 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.
Your qualifications should include:
· 3 years of experience in systems and database management
· Experience with sponsored research management / research operations software systems.
· Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), or Certified Clinical Research Coordinator (CCRC) is preferred but not required.
· Strongly preferred prior use of a grant management system
· Experience in sponsored research, academic, research environment or Comprehensive Cancer Center preferred.
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.







