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(Sr) Clinical Research Associate

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Aline Vandermeeren
Recruiter in Herent



Aline Vandermeeren
Recruiter in Herent
+32 16 30 95 09


Jobomschrijving

Clinical Site Start-up :

Support with identification of clinical sites

Preparation of packages for ethical committee (EC) submissions

Submissions to ECs

Preparation of site budget, negotiations of site budget

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

Clinical Site Management :

Organization, performance, follow-up of trainings

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

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

Site leadership

Development, writing, review of task-related SOPs

Support clinical supply chain

Profiel

  • 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 4 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
  • Fluent in Dutch, English and French
  • Strong communication skills
  • Professional attitude

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