Covance

  • CRA based in the Netherlands / Sponsor dedicated

    Job Location(s) NL-Amsterdam
    Job Number
    2019-27167
    Job Category
    Clinical Research Associates
    Position Type
    Full-Time
  • Job Overview

    Join Covance as a CRA and be dedicated to one of our main client based in Amsterdam. You would be joining the teams of ou Sponsor, an international pharmaceutical company known for being one of the main innovator in drug development (oncology, cardiology, endocrinology, rare disease...). You will be initially working on two immunology studies in start-up phase. 

     

    Be part of a dynamic team and join a work environment offering flexibility, career development perspective and energizing purpose! 

     

    This position is for a 0.8 or 1 FTE. We are llokin for a motivated and dedicated senior CRA, willing to work hard to achieve study goals. 

     

    Responsibilites: 

    • Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation
    • Prepare accurate and timely trip reports
    • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
    • Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
    • Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
    • Assist with training, of new employees, e.g. co-monitoring
    • Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

     

    Education / Qualifications

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

    Experience

    • Extensive Clinical Monitoring experience within a CRO or pharma environment
    • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Good planning, organization and problem solving abilities
    • Ability to work with minimal supervision
    • Good communication and interpersonal skills
    • Good analytical and negotiation skills
    • Fluent in Dutch and in English, both written and verbal

    If you are looking to broaden your therapeutic expertise whilst gaining exposure to a Pharmaceutical working environment this is a fantastic opportunity to seize now! 

     

    Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE.

     

    We are looking forward to hearing from you and welcoming you to Covance! 

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