Covance

  • CRA II / Senior CRA

    Job Location(s) NL-Amsterdam
    Job Number
    2018-23180
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    Covance is actively recruiting CRAs to be dedicated to one of our main client, a weel-known pharmaceutical company with offices in Amsterdam and at at the forefrint of Oncology development. 

     

    If you want to be part of a dynamic team and work environment offering flexibility, career development perspective and energizing purpose, apply now! 

     

    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

    • Minimum of 2 years of Clinical Monitoring experience.
    • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
    • 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! 

     

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

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