Lead CRA

For one of our clients located in the east of Brussels, we are looking for a Lead CRA.

  • Do you have a University degree or equivalent in Health Sciences ?
  • Do you have at least 3 years of experience as CRA? 
  • Are you fluent in English?

Then, you might be the candidate we are looking for !

Job Description 

As Lead CRA, you report to the Head of Monitoring Department and you are responsible to handle management of on-site monitoring activities.

Responsibilities 
You are responsible for the coordination of internal and/or external monitoring activities for a number of selected studies:
  • You develop and update study monitoring plan 
  • You ensure that visits schedule is compliant with study monitoring plan 
  • You review monitoring reports 
  • You provide advices to the CRAs in case of non-compliance issues
  • You track monitoring documents
  • You are responsible for the training and coaching of internal CRAs and external CRAs 
  • You provide support in the on-site monitoring visits conduct, whenever required
  • You perform co-monitoring visits in case of persisting site’s issues or to assess CRAs performance
  • You perform compliance visits in the framework of Intergroup trials coordinated by US Group
  • You ensure close collaboration between all actors of clinical trial research, as a privilege link between CRAs and the study team
  • You participate to Project Based MeetingsYou develop and maintain the procedures and templates related to monitoring activities
  • You participate to the maintenance of Monitoring tools 
  • You escalate recurrent minor or major quality issues to Head of Monitoring department 
Profile 
  • You have a University degree or equivalent in Health Sciences and you have at least 3 years of experience as a CRA.
  • You have practical knowledge about how clinical trials are conducted
  • You are fluent in English (written and spoken). Any other European language is an asset
  • A previous experience in Oncology is an asset
  • You are open to travel across European countries to support CRAs (5-10 days/year)
  • You have excellent organization and planning skills 
  • You pay attention to details
  • You are a problem solver
  • You have Good communication skills
  • You are proactive and dynamic
Contact Information 

Ariane d'Ansembourg
+32 10 68 53 30
ariane.dansembourg@valesta.com

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