Job Description
Your challenge
Responsibility:
• Monitoring of external and internal clinical performance evaluations and internal clinical trials (development studies, post-marketing complaints/observations)
• Preparation of relevant documents for clinical trials according to project requirments and internal processes
• "Preparation of study documents (e.g. templates/protocols)
• "Review of study documents (e.g. templates/protocols)
• Performance of site initiations, on-site monitoring, monitoring GBO-lab, remote monitoring and close-out visits
• Communication with investigators, opinion leaders, consultants, CRO, suppliers
• Filing of documents, TMF maintainance
• Training of study team members in accordance with protocol specific requirements and (local) regulations
• Support the (international) trials submission to authorities and ethics committees
• Ensuring the accuracy, validity and completeness of study data
• Trial sites feasibilities