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San Marcos

    Clinical Research Coordinator - San Marcos, United States - Medix™

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    Engineering / Architecture
    Description

    Clinical Research Coordinator Opportunity in San Marcos, TX

    **Prior Experience in Clinical Research is a Must**

    Overview of Responsibilities:

    The primary responsibility of the research coordinator is to coordinate research patient visits according to ICH-GCP guidelines and the IRB-approved study protocol. Daily tasks cover essential functions tailored to individual skills and organizational needs.

    Roles and Duties:

    • Facilitate and coordinate daily activities for clinical trials, playing a key role in study execution.
    • Administer sponsor-specified questionnaires, like VFQ.
    • Collaborate with team members to procure study supplies and maintain inventory.
    • Ensure thorough training of study staff on relevant information and document the process meticulously.
    • Create, manage, and maintain source documents for each trial.
    • Participate in teleconferences and Investigator Meetings if directed by the research director.
    • Review and understand study protocols, timelines, criteria, and privacy protections.
    • Work with teams to recruit eligible candidates and achieve enrollment targets.
    • Screen subjects for eligibility as per protocol criteria and document accurately.
    • Efficiently complete delegated study tasks like scribing, VFQ, IOP, etc.
    • Collect updated medical history and adverse event information for timely reporting.
    • Conduct informed consent discussions with research participants.
    • Ensure proper implementation and signing of consent forms.
    • Act as a secondary reviewer supervising the ICF process.
    • Enter protocol-required data into the EDC system within specified timelines.
    • Oversee data entry accuracy and resolve queries promptly.
    • Collect and report Adverse Events and Serious Adverse Events.
    • Ensure review of SUSAR/Safety Reports.
    • Coordinate monitor site visits and assist in documentation preparation.
    • Work with monitors to meet correction requirements.
    • Maintain all regulatory information for the study diligently.

    Additional Details:

    Location: San Marcos, TX

    Compensation: $55,000-$66,500 Annual Salary (Experience-based)

    Working Hours: Monday - Friday; Regular Business Hours (Onsite 5 Days a Week)

    Duration: Approximately 6-month Contract to Hire (~1,040 hours) transitioning into a permanent position

    Requirements: Prior Clinical Research Experience - Preferably 2+ Years as a Clinical Research Coordinator; Ophthalmology/Retina Experience is a Plus



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