Radius Health, Inc.

  • Clinical Trial Coordinator

    Job Locations US-MA-Waltham
    Posted Date 1 month ago(12/13/2018 1:30 PM)
    Job ID
    2018-1873
    # of Openings
    1
    Category
    Clinical Ops - Dept
  • Overview

    The Clinical Trial Coordinator (CTC) may support the development programs for all therapeutics areas. The incumbent will be responsible for supporting and assisting project teams with all study related operational tasks.

    Responsibilities

    • Maintains and schedules weekly team meetings and associated meeting agendas and minutes (draft, route for review, revise, distribute final to team and archive).
    • Tracks and distributes study specific documents such as operational, pharmacy, and lab manuals to contract research organization (CRO) and study sites if applicable.
    • Assists with preparing project status reports.
    • Supports other study related administrative tasks (scanning, emailing, filing, shipping, etc.).
    • Assists in the coordination of investigator meetings and studies presentation materials.
    • Collects, logs, tracks and files essential regulatory documents (TMF filing/coordinating) or verifies the documents are present in the CRO managed TMF.
    • Assists team members with travel accommodations, scheduling and expense reports.
    • May support clinical supply logistics.
    • Assist team members with contracting and PO’s.

    Qualifications

    • 1-2 years of clinical research experience in a pharmaceutical, biotech, CRO, or research center setting. Oncology experience is preferred
    • Requires a BS degree or equivalent work experience in lieu of a degree.
    • Excellent computer skills (Microsoft Office Suite, Outlook).
    • Experience working with essential regulatory documents and trial master file organization and structure preferred.
    • Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required.
    • Ability to work cross-functionally with various internal stakeholders 

     

     

     

     

     

     

     

    PM18

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