Lead CRA

Jobomschrijving

• Coordination of internal and/or external monitoring activities (i.e. monitoring reports review, advice on actions, tracking of visits schedule, monitoring documents, monitoring plan, monitoring budget)
• Training and coaching of internal CRAs and external CRAs
• Ensure the study CRA handover (internal CRAs)
• Participate to the maintenance of the QA&C tracking tools
• Provide assistance to the CRAs in the management of non-compliance issues
• Ensure close collaboration between all actors of clinical trial research, as a privilege link between monitoring actors and the study team.
• Perform co-monitoring visits
• Support in the Monitoring visits when required
• Develop and maintain the procedures and templates related to monitoring activities
• Escalate serious quality issues to Head of QA&C Unit

Profiel

• Master degree in life sciences
• At least 3 years experience as CRA
• Fluently in English. Dutch and French are a plus.
• Problem solver
• Great organisation and planning skills