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 successful candidate:

Under direct supervision of the Director, Clinical Research and/or Research Manager, the incumbent is responsible for supporting clinical trials at the top of their scope, for existing and novel oncology therapies while working in a fast-paced environment. Trial responsibility ranges from First in Human and Phase I-Phase III clinical trials, in addition to Therapeutic Investigator Initiated Trials (IIT's). The CSC position has a specific responsibility for all aspects of coordination of therapeutic trials in the various oncology disease areas supported at the site. The CSC must demonstrate an in-depth knowledge of applicable federal regulations, institutional guidance documents and SOPs for the conduct of clinical trials to ensure human subject protection, compliance with protocol and regulatory requirements and the thorough collection, recording and maintenance of data and source documentation.

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 CSC schedules and/or participates in off-site investigator meetings, pre-site selection visits, site- initiation visits, site-assessments, monitoring visits, and auditing activities as delegated by the Director, Clinical Research and/or Research Manager. The CSC may be responsible for and/or assist with completion and maintenance of regulatory documents in accordance with regulations, hospital and organizational policies and Standard Work Instructions. The CSC will participate in required training and education programs, provide clinical research education to local clinic staff, and ensure site research quality by practicing in compliance with policies, SWIs, principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. The CRC II may develop or assist with development of study tools for therapeutic trials including source documents, eligibility checklists, and criteria cards. They may also be involved in the collection, processing, and shipping of protocol required lab specimens. The CRC II maintains adequate supplies to conduct the studies and orders replacements as needed. The CSC maintains the equipment inventory (per protocol) and has appropriate certifications as required by protocol activities e.g., IATA certification. The CSC assists clinicians (LPNs, MAs, and/or RNs) as needed to ensure that protocol- required specimen collections, electrocardiograms, vital signs, study drugs dispensation, as well as follow-up observations are performed per protocol (as applicable).

Requirements:

• Minimum of 1 year research or relevant clinical experience

• Bachelor's degree in Science, Health or related field from an accredited university or related working experience.

• ACRP or SOCRA certification within 3 years of employment

• International Air Transport Association (IATA) within 1 month of employment

• Good Clinical Practice (GCP) within 1 month of employment

• Human Subjects Protection (HSP) within 1 month of employment

• Basic Life Support (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.