Clin Res Assoc II
Covance
Brussels, BE
8 dagen geleden

Overview

Covance is looking for a seasoned CRA to join our team and the one of one of our main client in Belgium!

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, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical or CRO industries may be considered
  • 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
  • Required :

  • Minimum of two (2) years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
  • 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
  • Ability to work with minimal supervision
  • Good communication and interpersonal skills
  • Good analytical and negotiation skills
  • Computer competency
  • Fluent in local office language and in English, both written and verbal
  • Works efficiently and effectively in a matrix environment
  • Preferred :

  • One (1) or more additional years of experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred
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