Senior Clinical Research Associate – Netherlands

• Conduct and coordinate clinical monitoring and site management activities
• Perform remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and ensure audit readiness
• Apply risk-based monitoring, root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification, and case report form review
• Assess investigational product inventory and records
• Document observations in reports and letters, escalate deficiencies, and follow issues through resolution
• Maintain contact with investigative sites between visits to confirm protocol compliance and timely data recording
• Track trial status and provide progress updates to the Clinical Team Manager
• Update clinical trial systems and perform quality-control checks of CTMS reports
• Participate in investigator meetings and identify qualified investigative sites
• Initiate clinical trial sites in accordance with protocol, regulatory, and ICH-GCP requirements
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and available according to ICH-GCP and applicable regulations
• Conduct on-site file reviews
• Assist with project publications and tools and perform additional study tasks assigned by the CTM
• Facilitate communication between investigative sites, the client company, and the project team
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Contribute to project work and process-improvement initiatives
• Travel frequently to site locations, generally 60–80%, with possible overnight stays

• Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent relevant formal academic/vocational qualification
• 2+ years of experience as a clinical research monitor
• Independent monitoring experience
• Valid driver's licence where applicable
• Effective clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Understanding and application of ICH GCPs, applicable regulations, and procedural documents
• Risk-based monitoring, root cause analysis, critical thinking, and problem-solving skills
• Oral and written communication skills for communicating with medical personnel
• Customer focus, listening skills, attention to detail, and ability to identify underlying issues
• Interpersonal, organizational, and time management skills
• Flexibility and adaptability
• Ability to work independently and as part of a team
• Proficiency in Microsoft Office and ability to learn appropriate software
• Fluency in Dutch and English
• Good presentation skills
• Ability to comply with sponsor/client/site requirements, including disclosure of vaccination status or other personal information

• Sign-on bonus guaranteed for qualified candidates
• Fully remote, hybrid, or office-based work options within the Netherlands
• Standard Monday–Friday work schedule