Covance

  • CRA II or Senior CRA - Sponsor Dedicated

    Job Location(s) BG-Sofia
    Job Number
    2018-21288
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    CRA position available to work directly with a large Pharmaceutical company. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Bulgaria. 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 Bulgaria 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.

     

    Duty Highlights:

     

    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

     

    Other Information:

     

    This CRA II or Senior CRA role is a full time & permanent position employed through Covance. 

    Education / Qualifications

    • University or college degree, or certification in related allied health profession from an appropriately accredited institution (e.g. nursing licensure)
    • Valid Driver’s License B
    • Thorough knowledge of CGP-ICH and basic understanding of the regulatory requirements

    Experience

    • At least 2.5 years of independent monitoring experience.
    • Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Previous experience in Phases II and III trials
    • Previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) in Bulgaria
    • Fluency in English and lñocal languaje

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Tell Us About Yourself

    Not ready to apply? Connect with us to join our talent community.