Clinical Research

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance in the management and execution of clinical trials
• Guide, oversee, and provide feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
• Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
• Ensure appropriate and timely investigator site visits
• Coordinate cross-functional departments to resolve clinical trial monitoring issues
• Assist with study-specific Monitoring Plans and training presentations
• Assist with ethics-document collection 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 problems, resolutions, protocol deviations, study progress, and enrollment
• Conduct source document review and verification to ensure CRF data integrity
• Perform quality control and verification of eTMF/TMF documents
• Conduct investigational product accountability
• Review site regulatory binders
• Maintain regular site contact to ensure protocol/GCP compliance and assess patient accrual
• Ensure compliance with ICH GCP, FDA regulations, and company/Sponsor SOPs
• Participate in internal, client/sponsor, scientific, and other meetings
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant-data queries with in-house CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Conduct audit preparation at study sites
• Support CRA collaboration and consistency
• Assist with CRA new-hire training and onboarding
• Mentor CRAs
• Collaborate on development and maintenance of the Clinical Trial Management System (CTMS)
• Manage conflicting priorities and deliver on commitments
• Perform additional assigned duties

Senior Clinical Research Associate

• 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

• Conduct site monitoring responsibilities for clinical trials independently
• Provide oversight, leadership, and guidance in the management and execution of clinical trials
• Ensure protocol compliance and quality
• Collaborate with clinical monitoring, CRA, in-house CRA, data management, project management, and sponsor teams
• Assist with study recruitment, site training, and site-related issues
• Provide guidance, oversight, and feedback to the CRA team
• Review monitoring visit reports and conduct co-monitoring and evaluation visits
• Ensure appropriate and timely investigator site visits
• Coordinate cross-functional departments to resolve clinical trial monitoring issues
• Assist with study-specific Monitoring Plans and training presentations
• Assist with 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 and timely monitoring visit reports
• Review and verify source documents and CRF data
• Perform quality control and verification of eTMF/TMF documents
• Conduct investigational product accountability
• Review site regulatory binders
• Maintain contact with study sites regarding protocol/GCP compliance, patient accrual, and sponsor requests
• Participate in internal, client/sponsor, scientific, and other meetings
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
• Resolve discrepant data queries with in-house CRAs/CTC and data management
• Identify site issues and develop problem-solving strategies
• Conduct audit preparation at study sites
• Assist with CRA new hire training and onboarding
• Mentor CRAs
• Collaborate on development and maintenance of the CTMS
• Manage conflicting priorities and deliver on commitments
• Perform additional assigned duties

• Act as line manager for trial monitoring staff (CRAs) in Belgium
• Plan, assign, and direct work; assess performance and guide professional development of direct reports
• Participate in hiring selection and allocate resources to clinical research projects
• Assign staff to clinical studies based on experience and training
• Ensure clinical trial protocols are executed according to ICH/GCP, local regulations, and applicable SOPs
• Collaborate with the Regional Clinical Operations Manager to maintain study timelines and quality standards
• Support study start-up and provide local expertise
• Manage study start-up and trial monitoring staff in accordance with company policies and regulations
• Ensure onboarding and training of new employees and oversee training plans
• Manage quality of assigned staff's clinical work through regular review and evaluation
• Provide country-specific study start-up expertise and review study documents, drug labels, ICFs, and templates
• Develop and review site-specific recruitment materials and tools
• Collaborate with study teams and clinical sites on IRB/EC submissions, TMF completeness, site activation, enrollment, and inspection readiness
• Contribute to feasibility, site identification, selection, and evaluation
• Perform accompanied CRA visits and assess performance
• Review visit reports, follow up on issue resolution, and communicate significant risks and proposed actions
• Monitor workload and quality metrics through regular review and reporting
• Anticipate and identify site issues, propose CAPAs, identify gaps, and leverage opportunities
• Promote operating excellence and innovation
• Contribute to Clinical Operations strategy and performance against key metrics
• Mentor and manage junior staff and Clinical Research Associates
• Act as escalation point for CRA site-related issues
• Conduct mid-year and year-end performance appraisals for direct reports

Clinical Research Manager

• Conduct and report all types of onsite monitoring visits
• Perform CRF reviews, source document verification and query resolution
• Manage site communication
• Manage sites
• Supervise study activities, timelines, and schedules for each site
• Act as a point of contact for in-house support services and vendors
• Support quality control, including compliance monitoring and report review
• Build and maintain relationships with clinical sites and investigators
• Ensure subjects’ rights, safety and well-being and quality of data compliance

Clinical Research jobs in Belgium

Senior Clinical Research Associate

Senior Clinical Research Associate

Senior Clinical Research Associate

Clinical Research Manager

Freelance Senior Clinical Research Associate