Covance

  • Sr Clinical Research Associate

    Job Location(s) TR-Istanbul
    Job Number
    2018-23929
    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 Instanbul. 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.  This will be an office based position however for the right candidate we can also offer some home working flexibility, 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 a phenomenal 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 cooperation 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/college degree (life science preferred)
    • In lieu of the above requirement, candidates with previous relevant clinical research experience in pharmaceutical or CRO industries will be considered
    • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory
      requirements in other countries
    • Thorough understanding of the drug development process
    • Fluent in local office language and in English, both written and verbal

    Experience

    • Monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
    • Have a full understanding of Serious Adverse Event (SAE) reporting, process production of
      reports, narratives and follow up of SAEs
    • Excellent study site management skills
    • Excellent registry administration skills
    • Ability to work with minimal supervision
    • Good planning and organization skills
    • Good computer skills with good working
      knowledge of a range of computer packages
    • Ability to train and supervise junior staff
    • Ability to resolve project-related problems and
      prioritizes workload for self and team
    • Works efficiently and effectively in a matrix environment

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