• Clinical Trial Associate

    Job Locations US-MA-Bedford
    Posted Date 4 weeks ago(12/26/2018 7:33 AM)
    Job ID
    2018-1173
    # 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
    • May also assist monitors on-site
    • Ability to travel approximately 25%

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