Covance

  • CRA II - Sponsor Dedicated

    Job Location(s) IT-Rome
    Job Number
    2018-21771
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    CRA II position available to work directly with a large Pharmaceutical company in the cutting edge area of Oncology. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Italy. 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 Italy 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 role is a full time & permanent position employed through Covance.

    Education / Qualifications

     

    • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure
    • Certification of Expert Monitor according to the Italian Ministerial Decree 15 Nov 2017
    • Valid Driver’s License B
    • Thorough knowledge of CGP-ICH and basic understanding of the regulatory requirements

     

     

     

     

    Experience

    • A minimum of 1 year of Clinical Monitoring experience
    • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
    • Good planning, organization and problem solving abilities
    • Good communication and interpersonal skills
    • Computer competency
    • Fluent in local office language and in English, both written and verbal
    • Work efficiently and effectively in a matrix environment
    • oncology experience (preferred)

     

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