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LCRA,Italy, home-based - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

  • Województwozagranica
  • Miejscowośćinne
  • AdresItaly,
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LCRA,Italy, home-based

Nr ref.: /JOBS.pl

  • Senior CRA Italy, Oncology Lead CRA duties

    Candidates with a varied therapeutic area background are encouraged to apply. You will work on exciting studies for some of the world's largest pharmaceutical companies and support project management as Lead CRA on projects.

    Key responsibilities will include:

    Developing, implementing and maintaining study documents, timelines, report formats, files, communication tools, budgets, and systems used in conducting a project

    Provide clear communication between levels of project: from team, to site and report to overall project leaders

    Perform routine site visits, including Pre-Study, Initiation, Routine and Closeout visits,
    compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance

    Assist Project Managers in study execution by acting as Lead CRA on projects and
    facilitating communication with Clinical Monitoring team

    Participate in TMF and on-site audits as requested

    Responsible for site management and site staff performance

    Participate in company-required training programs

    Participate on BID defense meeting

    Performs clinical data listings reviews as needed

    Train/Mentor junior CRAs on monitoring, internal procedures, and query resolution

    Provide a high level of administrative functions to assure smooth project running

    To be successful, the requirements for this opportunity include:

    Bachelor degree in life sciences, pharmacy, registered nursing or equivalent

    A minimum of 1-3 years' experience in clinical research

    Proven ability to work independently in a fast-paced environment

    Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

    Strong communication skills with the ability to build strong internal and external relationships

    Fluency in Italian and a high level of English language are required

    If this sounds appealing to you, please contact Franzi Dunker via email or via phone . The applications will be handed with discretion.


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