Hoag
Location
Newport Beach, California
Salary
$37 - $57 / HOUR
The Clinical Research Coordinator II manages all facets of clinical research trials, including planning, implementation, and closure, ensuring smooth and accurate processes in cooperation with physicians and sponsors. Responsibilities include protocol review, obtaining informed consent, managing study documentation, data collection, sample processing according to IATA standards, and adverse event reporting.
A High School Diploma is required along with 2-3 years of Clinical Research Coordinator experience, or equivalent training, demonstrating strong organizational, communication, and interpersonal skills. Preferred qualifications include knowledge of FDA/NIH/OHRP regulations, GCP guidelines, and potentially IATA Certification or Phlebotomy Technician certification.
Reporting to the Clinical Research Supervisor, Clinical Research Manager, or Director of Clinical Research Operations, the Clinical Research Coordinator II (CRC-II) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians, inter- and intradepartmental stakeholders, and sponsors. The CRC-II provides study management, support, and coordination for FDA regulated research industry-sponsored, government funded, and/or investigator initiated clinical research trials. This may include blood collection, data and trials that have therapeutic or device component. The CRC-II ensures smooth, accurate process of clinical studies from the planning, implementation, and post-study closure procedures. The CRC-II is involved in all aspects of the clinical research process included, but no limited to protocol review, preparation and administration of the informed consent, development of study treatment plans, completion of study related visit forms, ensuring protocol required assessments are completed per study guidelines, processing of lab samples per IATA standards, and regular communication with study sponsors and their collaborators. He/she will ensure accurate completion of case report forms (CRFs), adverse event/serious adverse event (SAE) reporting and scheduled subject follow-up visits. Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator or Sub-Investigator when appropriate) while obtaining informed consent. Responsible for development of study flow sheets, prepare study source documentation, gather study data, and assess subject for study eligibility (inclusion/exclusion). In addition, the CRC-II will record protocol specific assessments and treatments, ensure collection and shipment of samples, complete study forms to submit to sponsors and/or appropriate agencies, collect, enters and clean data into study database while maintaining data quality. I. He/she will host study team meetings, attend site initiation visits (SIVs) and perform other duties as assigned. Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research.
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