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    Clinical Research Coordinator - Phoenix, United States - Medasource

    Medasource
    Medasource Phoenix, United States

    4 weeks ago

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    Description

    Start Date: 5/20

    Contract: 6 month contract to hire

    Location: Onsite (Phoenix AZ).

    Responsibilities:

    • Coordinates and schedules subject study visits to ensure adequate supplies, procedures and investigator availability.
    • Provides study specific, individualized education to study subjects and families. 1.3 Ensures all appropriate subject consents are obtained. 1.4 Collects and processes protocol required specimens.
    • Acts as a liaison between Sponsor, Investigator, and Study Subject
    • Collects all required study data and completes CRFs in a timely, accurate manner.
    • Ensures study documents are maintained in compliance with applicable regulations, guidelines, and policies (i.e. FDA, OHRP, IRB)
    • Collaborates with Investigator to identify adverse events/ serious adverse events to ensure study subject safety and accurate and timely reporting.
    • Ensures appropriate internal and external customer service by demonstrating professional interactions with Sponsor, study monitors, and other departments.
    • Complies with all regulatory and policy requirements.
    • Demonstrates knowledge of federal and state regulations, guidelines, and policies governing the conduct of clinical trials.

    You will be supporting PI on several large, grant-funded Investigator Initiated Trials (or IITs). The person in this role will need to have strong coordinator experience and be interested in learning more about the specifics of enrolling in grant-funded IITs, the protocol development and study startup phases and reporting/documentation requirements for large R01 trials funded by the NIH involving Investigational Product (i.e. experimental treatments). The coordinator should have at least 3 years of experience as a clinical research coordinator and have strong skills related to creating source documentation, scheduling & conducting study visits, assessment & documentation of AEs/SAEs, lab collection and processing, etc. This person also needs to be familiar with the elements of a protocol and be able to take a critical eye to protocol documents to make sure these Investigator-created protocols contain all the necessary elements to be able to adequately gather the data required for the study objectives.

    Qualification:

    • Investigator Initiated Trial experience.
    • Being able to interpret protocol and ensure that its done correctly.
    • 3-5 year's experience minimum with clinical trials.
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