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