Clinical Trial Assistant

Job description

As a Clinical Trial Assistant (CTA) you hold an essential position within a clinical operations team. You are responsible for supporting clinical drug research by working closely with Clinical Research Associates and Clinical Project Managers. You are involved in study start-up, administration and filing of essential documents. 

  • Support during the feasibility process (e.g. preparation and follow-up of Confidentiality Agreements, retrieve completed Feasibility Assessments, complete feasibility tracker)
  • Coordinate translations of study documents
  • Assist in preparation of submission package to ECs/HA
  • Prepare documents for Site Initiation Visits (creation of site specific documents)
  • Set-up and distribution of Investigator Site Files
  • Set-up of study tracking tools
  • Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File to support readiness for audits and inspections
  • Logistic management of non-study drug related supplies/services
  • Support in local study process, presentations, mailing to sites, newsletters and correspondence
  • Assistance in preparation, support during conduct of audits and inspections
  • Support and follow-up of local team meetings and local investigator meetings (e.g. attendee list, agenda, meeting materials, writing of minutes)
  • Set-up of (e)TMF files and in-house filing of TMF documents in the appropriate files according to the SOP and ICH-GCP and other local guidelines
  • Support ongoing use of CTMS by maintaining and tracking relevant activities.
  • Minimum of a Bachelor’s Degree is required
  • Previous clinical research experience a plus
  • Requires previous administrative support experience for at least 1 year
  • Knowledge of Good Clinical Practices (GCP)
  • Belgian residence required, since this vacancy is office based

Demonstrated competencies/skills in the following areas are required:

  • Awareness and understanding of cultural differences as well as regional operational differences
  • Excellent written and verbal English communication skills, preferably also good knowledge of Dutch/French
  • Interpersonal, decision-making and issue resolution skills
  • Effective planning and organization skills
  • Computer skills (Microsoft office – Excel, Word and Power Point)
  • Attention to detail
  • Excellent follow through
Our offer
  • An attractive salary in line with your experience and skills
  • Fringe benefits including a company car, meal allowance, medical insurance, pension plan and a care plan
  • A supporting environment
  • Respect for the life-work balance
  • Career planning
  • A focus on professional and personal growth through training and coaching
  • Room for personal engagement to help shape our company's future
Brussels & Flanders
Contact person

Evelien Van Eecke

Personal profile
Contact details
Van Eecke
Clinical Talent Specialist

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+32 476 98 62 94