Clinical Research Associate

Published on 08/07/2022

Responsibilities

As a CRA in Artialis you will be a member of the clinical team and you will work closely with clinical project leaders, CRA and Data Manager for different clinical trials. You will be involved in each step of a clinical study including trial design, protocol writing, regulatory activities, clinical documentation and Master files, site management including feasibilities, SIV, MOV, COV, sample management and data management. More precisely your function/tasks will be the following:

• First line contact with investigating sites
• Site feasibility and selection including reports
• Site initiation, monitoring and close-out including reports in Belgium (Flanders, Wallonia and Brussels)
• Daily follow up of sites (email, phone call and teleconference)
• Training of sites
• Management and shipment of clinical materials and products
• Tracking and management of queries, issues and problems 2
• Preparation and management of clinical documentations
• Set up and maintenance of study files (electronic or paper TMF, ISF)
• Participation to eCRF design and database set up
• Management and resolution of protocol deviations
• External data reconciliation
• Safety management with sites
• Close communications with investigating sites, subcontractors, Project Leaders, CRA and Data Managers

Profile

  • Scientific background (BACHELIER or MASTER in Life Sciences)
  • Extend knowledge in clinical research
  • Extend knowledge in Site management and Monitoring
  • Previous experience as a CRA
  • GCP extend knowledge and training
  • Fluent in Dutch and French mandatory
  • Good knowledge of English (written and spoken)

Soft skills
  • Willingness to integrate a small structure where versatility and flexibility are key factors
  • Responsible attitude, rigor, tact and courtesy
  • Ability for quick adaptation and autonomy
  • Excellent communicative, organizational and planning skills
  • Excellent analytical skills to identify and understand problems and to propose and follow-up taken actions
  • Team spirit and able to collaborate closely with CPL, CRA and DM

Offer

You will integrate a growing familiar structure within a versatile environment and with an equilibrium between home and office-based work.

You will be part of a dynamic clinical team where you will be a key player and where you can grow and directly contribute to the success of clinical trials.

Application

You will integrate a scientific-driven and dynamic team and work in a respectful, human-sized and professional environment. You will be a key player in a great team, where you can grow and directly contribute to the success of clinical studies.

If you are interested to apply to this position, please send a covering letter and CV both in English to: berenice.costes@artialis.com (+32 485 491 494).
 

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