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 sponsor procedures and guidelines within the FSP team
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs
• Ensure audit readiness and develop collaborative relationships with investigational sites
• Monitor investigator sites using risk-based monitoring, including root cause analysis and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification and CRF review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Track trial status, provide progress reports to the Clinical Team Manager and update study systems/CTMS
• Participate in investigator meetings and identify qualified investigators and sites
• Initiate clinical trial sites and ensure compliance with protocol, regulatory and ICH-GCP obligations
• Ensure trial closeout and retrieval of trial materials
• Maintain complete essential documents and conduct on-site file reviews
• Assist with project publications, tools and other study tasks
• Facilitate communication between 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 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, or comparable experience
• Valid full driver's licence
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• 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
• Ability to communicate effectively with medical personnel
• Customer focus, listening skills and attention to detail
• Effective 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