Clinical Research Coordinator II: Digestive Health

Primary

Duties and Responsibilities

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.

• Hoag Memorial Hospital Presbyterian is a nonprofit regional health care delivery network in Orange County, California, consisting of three acute-care hospitals with sixteen urgent care centers, eleven health centers and a network of more than1,800 physicians, 100 allied health members, 8,000 employees, and 2,000 volunteers.
• More than 30,000 inpatients and 550,000 outpatients choose Hoag each year.