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Lead CRA

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Aline Vandermeeren
Recruiter



Aline Vandermeeren
Recruiter
+32 497 71 58 10


Description de l'emploi

The position reports to the Head of Monitoring department. 

The Lead CRA is responsible to handle management of on-site monitoring activities:

Coordination of internal and/or external monitoring activities: 

o Develop and update study monitoring plans 

o Ensure that visit’s schedule is compliant with study monitoring plan 

o Review monitoring reports 

o Provide advices to the CRAs in case of non-compliance issues

o Track all monitoring documents

Training and coaching of internal CRAs and external CRAs 

Perform co-monitoring visits in case of persisting site’s issues and/or to assess CRAs performance

Ensure close collaboration between all actors of clinical trial research, as a privilege link between CRAs and the EORTC study team

Participate to the Project Based Meetings

Develop and maintain the procedures and templates related to monitoring activities

Escalate recurrent major quality issues to Head of Monitoring department 


Profil

  • University degree or equivalent in Health Sciences 
  • Practical knowledge of the conduct of clinical trials 
  • Prior experience of at least 3 years as CRA 
  • Prior experience in Oncology is an asset
  • Excellent organization and planning skills 
  • Attention to details
  • Problem solver
  • Good communication skills
  • Proactive, dynamic
  • Languages: English (written & spoken) is mandatory; any other European language is an asset 
  • Full time availability


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Formation et expérience