Covance

  • CRA II - Sponsor Dedicated - Lisbon

    Job Location(s) PT
    Job Number
    2018-21721
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

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

     

    • Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets 
    • Join a stable team of CRAs across the country 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.

     

    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

    Fluency in English and Portuguese .

    University Degree in Life Science

    Experience

    At least 2,5 years of independent monitoring experience across phases II & III

    Strong Oncology experience

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