Radius Health, Inc.

  • Clinical Trial Coordinator

    Job Locations US-MA-Waltham
    Posted Date 2 weeks ago(7/9/2018 9:52 AM)
    Job ID
    2018-1764
    # of Openings
    2
    Category
    Clinical Ops - Dept
  • Overview

    Job Summary:

    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

    Essential 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.

    Qualifications

    Experience and Qualifications:

    • 1-2 years of clinical research experience in a pharmaceutical, biotech, CRO, or research center setting.
    • 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.

     

    The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet.   Frequent travel required.

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.

    Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.

     

     

     

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