Covance

  • Clinical Research Associate I - sponsor dedicated - Poland, Warsaw

    Job Location(s) PL-Warsaw
    Job Number
    2018-21725
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    We are currently looking for talented Clinical Research Associates to join our team in Warsaw.

    You would be working within our Flexible Solutions department dedicated to one sponsor/client.

     

    Would you like to work for one of the best known big pharma companies? Our sponsor is a global mid sized pharma company with high working standards. Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials. Do you like responsibilities and challenges? As a Clinical Research Associate you will lead all aspects of study site monitoring according to Covance SOP, ICH guidelines and GCP. You will take part in pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

    You will become a part of our team who is always ready to help. We offer a home based position so you will not spend time on unnecessary travels but at the same time we highlight a true live relationship between colleagues. You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.

     

    Our sponsor invests heavily in training and crafts modern system of Clinical Trials so if you are passionate about working with an outstanding team and expand your horizons feel free to reach us.

     

    Responsibilities include:

    • All details 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

     

    Education / Qualifications

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

     

     

     

    Experience

    Experience

    • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Excellent understanding of Serious Adverse Event (SAE) reporting
    • Ability to resolve project-related problems and prioritize workload for self and team
    • You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).

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