Covance

  • Clinical Research Associate II

    Job Location(s) DE
    Job Number
    2018-18310
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    Covance is searching for CRA II to be office based in Germany

     

    CRA II position available to work directly with a large Pharmaceutical company in the cutting of different therapeztic areas edge. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

    Requirements
    CRA II:
    - Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    - Excellent understanding of Serious Adverse Event reporting
    - Previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) in Belgium.
    - Fluency English, German

    USPs of CRA II role:
    - Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets 
    - Join a stable team of CRAs across Germany and benefit from outstanding training and development, both initially and throughout your career
    - Join a company where people tend to stay for 6-10 years rather than 1-3! 
    - Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.

     

    Duty Highlights:
    As a CRA you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. 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 degree or relevant job experience

    Experience

    Profound experience in independat monitoring

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Tell Us About Yourself

    Not ready to apply? Connect with us to join our talent community.