Clinical Research Coordinator

Salma Mazhar MD PA

Mesquite, TX

Full-Time

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