Covance

  • Clinical Research Associate II/ Sr CRA, Ukraine

    Job Location(s) UA-Kiev
    Job Number
    2018-24143
    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 Ukraine. You would be working within our Flexible Solutions department dedicated to one sponsor/client.

     

    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 or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
    • Minimum of 2 years of on-site Clinical Monitoring experience

    Experience

    • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements
    • Thorough knowledge of monitoring procedures
    • Basic understanding of the clinical trial process
    • 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).

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

    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.