Covance

  • Clinical Research Associate II/Sr CRA, Israel

    Job Location(s) IL
    Job Number
    2018-20053
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    We are currently looking for talented Clinical Research Associates to join our Clinical Operations team in Israel.

     

    We are proud to have an outstanding team of the best professionals on the market and are looking for people who are ready to show great performance and interest in Clinical Trials. As a Clinical Research Associate you will manage all aspects of study site monitoring according to Covance SOP, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
    You will become a part of our team who is always ready to help. You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.

     

    Responsibilities include:

    • All aspects of site management as prescribed in the project plans
    • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
    • Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
    • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
    • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems

    Education / Qualifications

    University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)

    Experience

    • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Excellent understanding of Serious Adverse Event (SAE) reporting
    • Ability to resolve project-related problems and prioritize workload for self and team
    • You must have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).

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