Research Associate - Rovigo (Provincia di Rovigo) - Veeda Lifesciences

    Veeda Lifesciences
    Veeda Lifesciences Rovigo (Provincia di Rovigo)

    1 giorno fa

    A tempo pieno
    Descrizione
    The Clinical Research Associate (CRA) will be responsible for ensuring that the conduct of clinical trials at selected Investigational Sites is in accordance with approved protocols, ICH GCP guidelines, Standard Operating Procedures (SOPs), and applicable laws and regulations. This includes verifying accuracy completeness and verifiability of collected data from source documents.

    Key responsibilities include:
    • Ensuring compliance with Company Quality Information Security Management Systems ICH GCP guidelines local and international legislation including data protection;
    • Reporting deviations from approved protocol to Line Manager other roles according to SOPs;
    • Collaborating with Regulatory Affairs Department Clinical Operations staff on clinical submissions contracts respectively;
    • Explaining trial purposes setup procedures to Investigators training them in conduct of clinical trials;
    • Preparing updating trial files ensuring proper collection of essential documents during trial;;
    Main Requirements
    /

    Education:

    Bachelor's or Master's degree preferably in Health Sciences;/

    Certification:

    Certified CRA;/
    • b Excellent English Italian oral written skills;
    • c Attendance of an ICH GCP training course desirable;
    • d Good computer skills
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