Job Description Job Description EXPERIENCE IN CLINICAL RESEARCH IS A MUST The Clinical Research Coordinator is responsible for managing the daily operations of a clinical investigation. This position will manage multiple, sponsored (Phase I, II, III, IV, and V) clinical trials for many indications within primary care. The Essential Job Functions are : * Maintain a detailed knowledge of all study protocols in order to complete all study activities correctly and completely * Recruit and screen patients for assigned studies * Provide instructions and education to subjects to ensure proper protocol compliance * Complete visit procedures including, but not limited to, obtaining vital signs measurements, performing ECG's, and collecting blood samples for processing and shipment to the appropriate lab facility * Notify the Investigator of all adverse events * Report all serious adverse events in compliance with FDA regulations and sponsor requirements * Provide the Sponsor with accurate and complete documentation and information * Complete and maintain accurate, legible and complete source documents and case report forms per FDA guidelines and Sponsor requirements * Prepare for FDA audit by ensuring all documentation and case report forms are available and complete. Ensure the rights, safety and welfare of all subjects at all times * Ensure that each subject has completed the informed consent process, following GCP guidelines, and has consented to participate before any study related procedures are performed * Provide subjects education on an ongoing basis throughout their participation in the protocol * Report all adverse events to the Investigator, Sponsor and IRB * Complete all relevant site-level and study-level logs in a timely manner * Utilize a team approach including the PI, Sub-Investigators, Site Manager, other Coordinators and Research Assistants * Act as a liaison to ensure complete and accurate communication between physicians, sponsors and subjects. Work in a collaborative, effective manner with the Sponsor to meet research objectives * Understand all internal policies and procedures approved by the Medical Director, Site Manager, and any other departments Job Type: Full-time Experience: * Clinical research coordinator: 2 year (Required) * Phlebotomy: 1 year (Required) * Vital Signs: 1 year (Required) Education: * High school or equivalent (Required) License: * CCRC/CCRP (Preferred)
Your site is a great one stop source for Clinical Research professionals.
- Dennis S. Colteaux, GPS Tech, Clinical Research TechJoin 4,249 other Clinical Research Professionals receiving FREE weekly job listings to their inbox every week.