• Clinical Research Associate II

    Job Location(s) DE
    Job Number
    Job Category
    Clinical Research Associate
    Position Type
  • 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!

    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


    Profound experience in independat monitoring


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