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Laura Schollen

Laura Schollen

Description de l'emploi

The CRA will strengthen our team within Clinical Operations Department, supporting our many projects. As an experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field of clinical research, you will be a productive member of the team. You enjoy start up, enrollment, follow up and closure of clinical trial activities, and mainly monitoring the progress of clinical studies at the site level.


• Clinical Site Start-up :

o Support with identification of clinical sites

o Preparation of packages for ethical committee (EC) submissions

o Submissions to ECs

o Preparation of site budget, negotiations of site budget

o Organization, preparation, performance, follow-up of Site Qualification visits, Site Initiation visits

• Clinical Site Management :

o Organization, performance, follow-up of trainings

o Organization, preparation, performance, follow-up of Monitoring visits, Close-out visits

o Identification, communication, resolution of site-related matters, issue escalation

o Site leadership

• Development, writing, review of task-related SOPs

• Support clinical supply chain


  • Bachelor or Master degree in (para-) medical or scientific field
  • Involvement in study start-up and EC submissions in at least 2 countries
  • At least 3  to 5 years of clinical research experience including monitoring, or in pharmaceutical data management including activities during data base locks, or as a study coordinator
  • Experience with oncology in early phases
  • Experience with Advanced Therapy Medicinal Products (ATMPs) is an advantage 
  • Very strong attention to details
  • Work precisely as per procedures, rules and regulations
  • Objective and analytical
  • Planning & Organizing skills
  • Team spirit
  • Excellent English, French and Dutch knowledge (“trilingual”, oral and written), additional languages are an asset
  • Strong communication skills
  • Hands-on attitude


Freelance/ permanent position 

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