Clinical Research Coordinator - 248861 - Appleton - Medix™

    Medix™
    Medix™ Appleton

    7 hours ago

    Engineering / Architecture
    Description

    **SEEKING A CLINICAL RESEARCH COORDINATOR IN APPLETON, WI**

    Location: Appleton, WI

    Pay range: $50,000-$75,000

    *Full benefits

    Clinical Research Coordinator – Key Responsibilities:

    • Facilitate and coordinate daily clinical trial activities, ensuring protocol adherence and study integrity.
    • Administer sponsor-required questionnaires, such as the VFQ, according to study timelines.
    • Collaborate with designated team members to ensure adequate inventory of study supplies, lab kits, and shipping materials.
    • Ensure study staff are properly trained on protocol-specific procedures, informed consent forms (ICFs), and study manuals; document all training accordingly.
    • Create, manage, and maintain accurate source documents for each clinical trial.
    • Attend sponsor teleconferences and Investigator Meetings as assigned by the research director.
    • Review and comprehend study protocols, including timelines, inclusion/exclusion criteria, and confidentiality protections.
    • Collaborate with study and clinical teams to recruit, screen, and enroll eligible participants in alignment with study enrollment goals.
    • Accurately screen subjects based on inclusion/exclusion criteria and document eligibility findings.
    • Complete delegated study-related tasks such as scribing, administering VFQ, and measuring intraocular pressure (IOP).
    • Collect and update medical histories, and report adverse events (AEs) and serious adverse events (SAEs) to the sponsor and IRB within required timelines.
    • Conduct and/or participate in informed consent discussions with participants; ensure understanding and address questions.
    • Implement and verify use of amended consent forms; act as a secondary reviewer to ensure accurate ICF execution.
    • Collect study data per protocol guidelines and enter data into Electronic Data Capture (EDC) systems within the contracted timelines.
    • Oversee the accuracy of entered data, resolve data queries promptly, and ensure all EDC entries are compliant with protocol and sponsor expectations.
    • Collect and report all Adverse Events (AEs), Serious Adverse Events (SAEs), and SUSARs in compliance with regulatory guidelines.
    • Coordinate and prepare for monitor site visits; assist with the completion and submission of visit documentation.
    • Collaborate with monitors to address and correct findings in a timely manner.
    • Manage and maintain regulatory documentation, including protocols, investigator brochures, IRB approvals, disclosures, CVs, and training records.
    • Obtain and maintain required sponsor trainings and certifications as applicable to assigned clinical studies.

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