Clinical Study Coordinator

Updated: about 15 hours ago

Clinical Study Coordinator

Join the transformative team 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. 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 treatment facilities in Atlanta, Chicago and Phoenix. our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.

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 Clinical Study Coordinator (“Study Coordinator") position has a specific responsibility for all aspects of coordination of therapeutic trials in the various oncology disease areas supported at the site.

The Clinical Study Coordinator 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 Clinical Study Coordinator collaborates with Investigators in review of subjects’ recruitment and pre-screening efforts for protocol eligibility. The Clinical Study Coordinator is responsible for developing an individualized strategy for recruitment and retention of their assigned trials. The Clinical Study Coordinator 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 Clinical Study Coordinator may provide education on investigational agents/devices to research subjects and maintains test article accountability. In collaboration with Investigators, the Clinical Study Coordinator monitors subjects for changes in condition, adverse events, concomitant medication use, protocol compliance, response/reactions to test articles, and thoroughly documents all findings. The Clinical Study Coordinator is responsible for accurate and timely data collection, documentation, and reporting.

The Clinical Study Coordinator 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 Clinical Study Coordinator 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 Clinical Study Coordinator 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 Clinical Study Coordinator 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 Clinical Study Coordinator maintains adequate supplies to conduct the studies and orders replacements as needed. The Clinical Study Coordinator maintains the equipment inventory (per protocol) and has appropriate certifications as required by protocol activities e.g., IATA certification. The Clinical Study Coordinator assists clinicians (LVN/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).

Position Qualifications:

  • Minimum Education: Bachelor’s degree in Science, Health or related field from an accredited university; 3 additional years of experience plus the minimum experience requirement may substitute for minimum education.
  • Minimum Experience: Minimum of 2 years research or relevant clinical experience
  • Req. Certification/Licensure: − ACRP or SOCRA certification within 1 year 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
  • Preferred Experience: Minimum 3+ years of oncology experience or, Phase 1 clinical trial experience

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here .

To learn more about our comprehensive benefits, click here: Benefits Information

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