Clinical Study Coordinator About City of Hope, City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope's uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. The CSC collaborates with Investigators in review of subjects' recruitment and pre-screening efforts for protocol eligibility. The CSC is responsible for developing an individualized strategy for recruitment and retention of their assigned trials. The CSC presents trial concepts and details to the research subjects, participates in the informed consent process, enrolls, and coordinates care of subjects in compliance with protocol requirements. The CSC may provide education on investigational agents/devices to research subjects and maintains test article accountability. In collaboration with Investigators, the CSC monitors subjects for changes in condition, adverse events, concomitant medication use, protocol compliance, response/reactions to test articles, and thoroughly documents all findings. The CSC is responsible for accurate and timely data collection, documentation, and reporting.
The successful candidate:
Possesses a basic awareness of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations.
Possesses a basic awareness of the operations of the Institutional Review Board and its requirements of the protection of human subjects Reads, acknowledges, understands, and agrees to follow all COH CRI Policies and Procedures
when necessary, records data from source documentation into case report forms with awareness and attention to the requirements for accuracy, completeness and source documentation, Adhering to ALCOA-C+ guidelines.
Coordinates research subject care (clinic appointments, laboratory schedules, procedures, etc.) to ensure protocol compliance
Performs research required activities within the scope of technical expertise and training including vital signs, blood draws, collection, processing, and shipping of biospecimens, subject, and clinical observations.
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about protections for human participants of research.
Performs procedures for research as they are described in the protocol in accordance with credentials such as, ECGs etc., deviating from the protocol only when a subject's safety is at risk and reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other safety assessments are required
Requirements:
Minimum of 1 year research or relevant clinical experience BS in Science, Health or related field or related work experience ACRP or COCRA certification within 3 years of employment International Air Transport Association within 1 month of employment Good Clinical Practice (GCP) within 1 month of employment Human Subjects Protection (HSP) within 1 month of employment BLS within 1 month of employment
City of Hope is an equal opportunity employer. To learn more about our comprehensive benefits, click here:Benefits Information City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.
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