Take ownership of clinical study monitoring
- You conduct site qualification, initiation, monitoring, and close-out visits — both on-site and remotely
- You create clear, high-quality visit reports and keep everything on track within given timelines
- You stay closely connected with your study sites, ensuring continuous support and follow-up
- You ensure compliance with protocols and regulations (ISO 14155, GCP, EU MDR, FDA, etc.)
- Most importantly, you safeguard the rights, safety, and well-being of study participants
Ensure data quality you can trust
- You support submissions to Ethics Committees and competent authorities
- You review and verify clinical data against source documentation, ensuring accuracy and completeness
- You monitor informed consent processes and documentation
- You ensure timely and accurate entry of data in EDC systems
- You identify, document and follow-up on data queries, deviations, and open action items
Drive quality & compliance excellence
- You keep Trial Master Files and site documentation audit-ready at all times
- You identify and report protocol deviations, adverse events, and other critical findings in accordance with regulatory and internal requirements
- You support audits and inspections with confidence
- You assist with contracts, invoices, and other study related financial aspects
- You follow — and help strengthen — SOPs and quality standards
Build strong site relationships
- You act as a trusted partner to investigators and site staff
- You train and guide sites on protocols, devices, and procedures
- You create a positive, collaborative study environment
