Covance

  • SCRA - Austria

    Job Location(s) AT
    Job Number
    2018-17553
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    CRA 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 Austria. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

     

    Requirements

     

    Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

    Excellent understanding of Serious Adverse Event reporting

    Previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) in Austria

    Fluency in English and German.

     

    USPs of CRA II role:

     

    Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets 

    Join a stable team of CRAs across the Netherlands 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.

    ONCOLOGY Focussed

     

    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. 

     

    Key words:

    CRA II, CRA I, Clinical Research Associate, Oncology, Clinical Monitor, Immunotherapy, CRA II, Cancer Clinical trials, Senior CRA

    Education / Qualifications

    Life Science Background

    Training in GCP

    Experience

    • Clinical research experience essential 
    • People management experience
    • Strong leadership skills
    • Knowledge in Site Management
    • Strong organizational skills with demonstrated success required.
    • Position requires excellent oral and written English language skills

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