Upsilon Global

Clinical Trial Assistant - Ghent region - Sponsor dedicated

Expiring today

Ghent, Gand (BE)
€1900 - €2400 net per month
04 Feb 2021
06 Mar 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Upsilon Global have partnered with one of our frequent CRO collaborators who are seeking a permanent CTA to work sponsor dedicated for an exciting, growing Biotech who have a strong focus on immunology and immuno-oncology.

Main Responsibilities

  • You will work on Clinical Trials by assisting the Clinical Trial Manager(s) (CTM) with the conduct of the assigned clinical trial(s) (administration, coordination, archiving)
  • May assist the Clinical Operations Lead (COL) with organizing the Clinical Team Meetings
  • Help the Head of Clinical Operations with the development of template documents to be used within the Department as well as with the logistics of the departmental meetings
  • The CTA assists the CTM 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 for CDAs, contracts, POs and insurance certificates in collaboration with CTM/Director Vendor Management
  • Develops and adapts documents to trial specific requirements in collaboration with the CTM
  • 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, including but not limited to trial team meetings, Investigator Meetings.
  • Assists the CTM/COL 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

Education And Qualifications

  • Minimum of 3 years of experience as a CTA
  • Speaks and writes English fluently, any additional level of Dutch would be beneficial, but not essential
  • Knowledge of ICH-GCP
  • 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, IXRS
  • Experience of working within a Biotech would be beneficial, but not essential
  • You must be based within a commutable distance to Ghent is this role is part office/part home based once we are post COVID-19

Please don't hesitate to get in contact with me on +44 203 875 9966 or for any further questions you may have about the vacancy!

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