Clinical Research

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance to CRA teams
• Ensure adherence to project scope, SOPs, timelines, budgets, protocol, GCP, and regulatory requirements
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Ensure timely investigator site visits
• Coordinate cross-functional issue resolution for clinical trial monitoring
• Assist with Monitoring Plans, training presentations, ethics documents, and site contract negotiation
• Provide monthly billing information to finance
• Manage study budgets and act as sponsor referent for stand-alone projects
• Perform qualification, initiation, interim, and close-out visits remotely and onsite
• Prepare accurate monitoring visit reports covering site issues, resolutions, protocol deviations, study progress, and enrollment
• Verify source documents and CRF data integrity
• Perform quality control of eTMF/TMF documents and investigational product accountability
• Review site regulatory binders
• Maintain site contact, assess patient accrual, and respond to sponsor requests
• Facilitate adverse event reporting and SAE reconciliation
• Resolve discrepant data queries with in-house CRAs, CTC, and data management
• Identify site issues and develop problem-solving strategies
• Prepare study sites for audits
• Mentor and train CRAs, including new-hire onboarding
• Collaborate on CTMS development and maintenance
• Manage conflicting priorities and perform additional assigned duties

Clinical Research jobs in Netherlands

Senior Clinical Research Associate