Salma Mazhar MD PA
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.
Responsibilities
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 ECGs, 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) Education
High school or equivalent (Required) License
CCRC/CCRP (Preferred)
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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 ECGs, 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) Education
High school or equivalent (Required) License
CCRC/CCRP (Preferred)
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