Clinical Research Associate – Level I

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage clinical trial documentation and ensure audit readiness
• Apply risk-based monitoring, including root cause analysis, corrective/preventive actions, SDR, SDV and CRF review
• Assess investigational product inventory and records
• Document and escalate deficiencies, track issues through resolution and maintain site contact between visits
• Provide trial status tracking and progress reports to the Clinical Team Manager
• Update and quality-check clinical trial management systems
• Participate in investigator meetings and identify and initiate qualified investigative sites
• Ensure trial closeout and retrieval of trial materials
• Maintain essential documents and conduct on-site file reviews
• Support project publications, tools and additional study tasks
• Facilitate communication among investigative sites, the client company and the project team
• Respond to company, client and regulatory audits and inspections
• Complete expense reports and timesheets
• Contribute to process-improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• 6 months–1 year of experience as a clinical research monitor
• Valid full driver's licence
• Effective clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Understanding and application of ICH GCPs, applicable regulations and procedural documents
• Critical thinking, root cause analysis and problem-solving skills
• Ability to manage Risk Based Monitoring concepts and processes
• Effective oral and written communication skills with medical personnel
• Customer focus, listening skills and attention to detail
• Interpersonal, organizational and time management skills
• Flexibility and adaptability
• Ability to work independently and in a team
• Proficiency in Microsoft Office and ability to learn appropriate software
• Good Dutch, French and English language and grammar skills
• Good presentation skills

• Fully remote work arrangement
• Standard Monday–Friday work schedule