Lead CRA

The position reports to the Head of Monitoring department.

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

Main responsibilities / activities

  • Coordination of internal and/or external monitoring activities for a number of selected studies:
    • Develop and update study monitoring plan
    • Ensure that visits schedule is compliant with study monitoring plan
    • Review monitoring reports
    • Provide advices to the CRAs in case of non-compliance issues
    • Track monitoring documents
  • Training and coaching of internal CRAs and external CRAs
  • Provide support in the on-site monitoring visits conduct, whenever required
  • Perform co-monitoring visits in case of persisting site’s issues or to assess CRAs performance
  • Perform compliance visits in the frame of Intergroup trials coordinated by US Group
  • 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
  • Participate to the maintenance of the Monitoring tools
  • Escalate recurrent minor or major quality issues to Head of Monitoring department

Profile

  • 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
  • Ability to travel across European countries to support CRAs
  • Excellent organization and planning skills
  • Attention to details
  • Problem solver
  • Good communication skills
  • Proactive, dynamic
  • Full time employee
  • Languages: English (written & spoken) is mandatory; any other European language is an asset

Application form


*Compulsary fields
Application should be sent in English

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