• Clinical Trial Associate

    Job Locations US-MA-Bedford
    Posted Date 4 months ago(2/25/2019 12:08 PM)
    Job ID
    2019-1200
    # of Openings
    1
    Category
    Clinical
  • Overview

    Executes coordination of activities associated with the set-up and management of clinical trials. Responsible for retrieval and management of regulatory documentation for site activation, maintenance, and close-out.

    Responsibilities

    Independently executes the following activities with limited oversight:

    •Clinical trial tracking activities beginning at the study feasibility stage through trial close-out
    •Preparation of study documents (i.e. consent form, site instructions, etc.)
    •Identification of investigators for participation in clinical trials
    •Prepares final copies of monitor workshops and investigator meeting materials
    •Completes administrative tasks throughout all stages of clinical trial execution
    •Files regulatory documents and provide the associated metric reports
    •Communicates and takes action when metrics actuals deviate from plan. Escalates as appropriate to CRA or CPM
    •Routinely reviews databases and generates metric reports to provide to tea
    •Work with CRAs/RCRAs to ensure study supplies are present at sites (drug supplies, lab supplies, necessary equipment, e.g., Portable ECG)
    •Drafts, sends for review, incorporates comments and finalizes meeting minutes
    •Reviews meeting minutes to track action item completion
    •Reviews and track site and vendor invoices and payments
    •Maintains TMFs
    •May accompany monitors at site visits to complete regulatory binder reviews

    Qualifications

    •Bachelor's Degree in a Health or Science field preferred
    •Minimum of 2 years of related experience
    •Excellent written and oral communication skills
    •Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
    •Excellent organizational skills and attention to detail
    •Some travel would be required for site training, meetings and educational seminars

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