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Clinical Research Coordinator

2 months ago

Nashville, United States Medix™ Full time

The candidate will be coordinating clinical research protocols from study start up to close out. This candidate will work closely with all research staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization and Good Clinical Practices.


Responsibilities:

• May be the sole coordinator or work in collaboration with a research nurse on studies, responsible for source documents, data collection, data entry, query resolution, triggering financial payments, study close out and liaison with the sponsor/CRO


• Participates in the identification of potential clinical trial participants, screens them for eligibility, and enrolls participants per protocol


• Coordinates the schedule of events for clinical trial participants from screening to follow up according to protocol


• Collects, verifies, organizes and records clinical information and data in electronic data capture systems (EDC). Abstracts data from necessary sources to complete the EDC and resolve queries. Performs the following data related activities: EDC tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding


• May be responsible for regulatory submissions. Need working knowledge of essential documents and IRB requirements


• Participates in site feasibility determination, site qualification visits, site initiation visits and research related meetings


• May be responsible for recruiting clinical trials to site


• May have patient contact


Qualifications:

Would not need phlebotomy experience, preferred CCRC.

2 years of CRC experience.

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