Covance

  • CRA I - Entry Level - Sponsor Dedicated (Temp)

    Job Location(s) PT-Lisbon
    Job Number
    2018-23761
    Job Category
    Clinical Research Associate
    Position Type
    Temporary
  • Job Overview

    CRA position available to work directly with a large Pharmaceutical company in the cutting edge area of Oncology. As a 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

     

    • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)
    • In lieu of the above requirement, minimum of with six month on-site monitoring (preferred)
    • 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
    • Valid Driver's Lecense

    Experience

    • Minimum of six months of on-site monitoring (preferred)
    • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Good planning, organization and problem solving abilities
    • Ability to work within a project team
    • Good communication and interpersonal skills
    • Good analytical and negotiation skills
    • Good computer skills
    • Fluent in local office language and in English, both written and verbal
    • Works efficiently and effectively in a matrix environment

    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.