• Temp Clinical Trials Associate

    Job Locations US-MA-Bedford
    Posted Date 3 weeks ago(6/26/2018 10:09 AM)
    Job ID
    2018-1088
    # of Openings
    1
    Category
    Clinical
  • Overview

    Participates in clinical research programs by implementing procedures to track contract execution, invoices and product shipments; updating standard operating procedures; preparing pre-study document packages for distribution to study sites; managing the procurement and preparation of study supplies and equipment; interfacing with study vendors to ensure adequate provision of supplies throughout the study; data entry; creation of clinical trial master files; review of regulatory documents for assurance of quality and supporting multiple clinical trials.

    Responsibilities

    •Ensure that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements
    •Set up and maintain clinical trial and site investigator files
    •Review study records including case report forms, consent forms, and other materials
    •Responsible for ordering, shipping and keeping inventory of all study product and supplies for clinical sites
    •Assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting and reviewing data in a timely manner that meets the protocol requirements
    •Organize and track payments to sites on a routine basis
    •Serve as a resource to Ocular Therapeutix Clinical Affairs site coordinators, investigators, and other staff members regarding investigational products and protocols
    •Interface with clinical, regulatory, sales, marketing and administrative staff as necessary to accomplish the above responsibilities

    Qualifications


    •Bachelor's Degree in a Health or Science field preferred
    •Excellent written and oral communication skills
    •Computer literacy, proficiency in MS Word, Excel, Power Point, etc.
    •Excellent organizational skills and attention to detail
    •Ability to travel approximately 10% of the time for site training, meetings and educational seminars

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