Clinical Research Coordinator
4 days ago
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
Experience:
- Clinical research coordinator: 2 year (Required)
- Phlebotomy: 1 year (Required)
- Vital Signs: 1 year (Required)
- High school or equivalent (Required)
- CCRC/CCRP (Preferred)
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