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    lead clinical research coordinator - El Paso, United States - HARACEC COMPLETE HEALTHCARE PLLC

    HARACEC COMPLETE HEALTHCARE PLLC
    HARACEC COMPLETE HEALTHCARE PLLC El Paso, United States

    3 weeks ago

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    Description

    Job Description

    Job Description

    Manage multiple clinical trials ranging in everything from study start-up through study close-out following study protocol, GCP, and SOPs. At the same time, maintaining communication with central and local IRB and maintaining all applicable regulatory requirements. Together with working directly with study sponsors in contracts and budgets.

    Specific responsibilities:

    · Conduct daily execution of protocol including obtaining informed consent, and executing SOE/study procedures.

    · Maintain proper source data documentation on CRFs together with ensuring GCP guidelines, performing data entry, and query resolution.

    · Monitoring subject safety and ensuring subject compliance with the study protocol.

    · Preparation of IRB applications, protocol, and informed consent approval to conduct the study. Appropriately maintaining communication with the IRB regarding AE/SAEs renewals and protocol amendments

    · Assist in the creation of SOPs for each study and ensure compliance with regulatory, ICH guidelines requirements.

    · Working in close communication with study monitors in maintaining double-blind protocol while administering IP, performing drug accountability, temperature monitoring, and storage requirements.

    · Maintaining and creating study-related supplies in stock, devices, and IP triggering with IRT to expedite shipment of IP when stock is needed.

    · Responsible for clinical tasks related to protocol, and properly following lab manual instructions when processing biological samples.

    · Recognizing adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify the Principal Investigator, Sponsor, and site regulatory coordinator. Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in the protocol.



    Monday through Friday, 8AM to 5PM
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