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CLINICAL RESEARCH COORDINATOR - CLINICAL RESEARCH CANCER
Newport Beach, CA Reporting to the Director, Clinical Research, the Clinical Research Coordinators (CRC) are responsible for all aspects of clinical research activities and work in close cooperation with study physicians. The CRCs provide support, coordination, and leadership for FDA-regulated research including drug/device/biologic studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials, government-funded clinical research and investigator-initiated clinical research. The CRCs ensure the smooth, accurate process of clinical studies from the planning and approval stages through study completion and post-study closure. The CRCs are involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, study submission to the Institutional Review Board, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, scheduled subject follow-up, and maintenance of regulatory binders. Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator when appropriate) while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled subjects. The CRCs assist in developing detailed cost analysis, study budget preparation, and tracking/distribution of study funds. Responsible for submitting case report forms and other data to the Sponsor as necessary, and assists with monitoring, auditing, and close-out visits. Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research. Specific duties may include designing, implementing, and managing a system for organizing, planning workflow related to all research study activities. Assist the PI in the active recruitment and screening of potential research participants. Discuss research study with potential research participants. Performs other duties as assigned. EDUCATION AND EXPERIENCE: *Must have an AA degree or current ACRP or SoCRA Certification. *Minimum 1 (one) year of Clinical Research Coordinator experience. *Patient coordination experience in complex clinical trial settings required (does not include Regulatory position). *Medical terminology required. Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines. *Understanding of clinical trial methodologies and experience filing Institutional Review Board documents. Knowledge in one assigned clinical area. CERTIFICATIONS REQUIRED: *If no AA degree must show proof of current ACRP or SoCRA Certification. |
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