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

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


    • 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


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