Experienced Clinical Trial Assistant

 

Client

Several clients are looking for (experienced) Clinical Trial Assistants. Clients are CROs, pharmaceutical companies, … and located in different regions (e.g. Brussels region, Antwerp region).

Main purpose

The CTA is supporting a wide range of clinical studies. The CTA is an essential member of the clinical study conduct team. The incumbent will provide operational project support and is responsible for in-house or on-site activities as well as for compliance with processes required to initiate, maintain, support and close out the clinical trials managed by the department.

Tasks

  • Assemble and provide support for timely Clinical Trial Submissions and availability of Essential Documents for clinical trials.
  • Act as relationship manager with 3rd party vendors or with support groups such as ancillary supplies management.
  • Create Essential Documents Repository.
  • Assemble and track availability of all essential documentation required for study conduct.
  • Provide professional presentation of study materials for investigator/vendor or country operations meetings.
  • Safety reporting tracking.
  • Liaise with sites and in house departments to ensure appropriate regulatory follow-up.
  • Organization and documentation (minutes) of project team meetings
  • Operational and project support activities, including, but not limited to:
    • archiving and/or accountability for completeness of Trial Master File
    • update, maintain and monitor CTMS (Clinical Trial Management system) to allow accurate project management, regulatory reporting and clinical grants payments
    • follow-up/check final accountability of IMP and return or destruction as appropriate
    • review study budgets/clinical trial agreements for consistency with study protocol
    • updating of clinical and study planning databases

Requirements

  • Understanding and knowledge of study protocols and study working documents
  • Interpersonal skills and ability to work in a team environment
  • Advanced organization and planning skills
  • Advanced communication skills (written and verbal) in local languages (Dutch and French) and English
  • Advanced computer skills: e.g. professional using of MS Office programs for daily business
  • Good understanding of the clinical research processes
  • Understanding of the ICH/GCP (international good clinical practice guidelines and harmonization) and local clinical trial regulations
  • Education & Experience bachelor degree (e.g. medical assistant, or paramedical education) or relevant work experience in clinical research field
  • Preferably a mature person with experience in a similar environment

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