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Sr CRA

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Laura Schollen
Recruiter



Laura Schollen
Recruiter


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.

Responsibilities:

• 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

Profil

  • 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

Offre

Freelance/ permanent position 

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