Clinical Trial Assistant – Belgium

Excelya>Full-time>Clinical Trial Assistant – Belgium

Job description

Job description

The Clinical Trial Assistant (CTA) works on clinical trials by assisting the study team with the conduct of the assigned clinical trials: administration, coordination, archiving.

 

Responsibilities

The CTA assists with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Standard Operation Procedures (SOPs):

  • Assists with signature collection, contracts, POs and insurance certificates in collaboration with team members
  • Develops and adapts documents to trial specific requirements in collaboration with the trial team
  • May assist with the preparation of trial reports for the trial team and keeping them up-to-date
  • Assists with organizing (agenda, meeting minutes, follow-up on action items) trial specific meetings
  • Assists the PM to ensure that the essential trial documents at sponsor level are properly filed and made ready for archiving.
  • Provides input to the other departments outside Clinical Operations to ensure that the needed documents are filed within the (e)TMF.
  • Assists in (electronic) Trial Master File review (TMF) to confirm completeness and follow-up of findings
  • Assist with the organization of the clinical team meetings (agenda, meeting minutes, follow-up on action items)
  • Support to development of template documents to be used within the department

Profile

Requirements

  • Bachelor’s degree or University degree – medical or equivalent by experience
  • > 2y of experience in similar position within Clinical Operations
  • Proactive, hands-on, confident, strong communicator
  • Biotech experience is a plus
  • Knowledge of GCP
  • Language: English
  • Knowledge of (e)TMF
  • Proficient in software applications such as Outlook, Word, Excel and PowerPoint
  • Experience with tools and systems for managing clinical trials such as MS project, trial progress and metric systems, eCRF, IRT

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