Senior Clinical Research Associate – Client-dedicated FSP

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor or monitoring-environment procedures
• Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations and SOPs
• Maintain audit readiness and collaborative relationships with investigational sites
• Monitor investigator sites using risk-based monitoring, including root cause analysis, corrective/preventive actions, SDR, SDV and CRF review
• Assess investigational product inventory and records
• Document observations in reports and letters, escalate deficiencies, and follow issues through resolution
• Maintain contact with sites between monitoring visits to confirm protocol adherence, issue resolution and timely data recording
• Conduct monitoring according to approved monitoring plans and participate in investigator payment processes
• Track trial status and provide progress updates to the Clinical Team Manager
• Update and quality-check study systems including CTMS
• Participate in investigator meetings and identify potential investigators with the client
• 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, trip report reviews, newsletters and CRA team calls
• 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 promptly
• Contribute to project work and process-improvement initiatives

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification
• Previous independent monitoring CRA experience
• 2+ years as a clinical research monitor or comparable experience
• Valid full driver's licence
• Fluency in Dutch, English and French
• Effective clinical monitoring skills
• Understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated 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, attention to detail and ability to identify underlying issues
• Effective interpersonal skills
• Strong 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
• Ability to comply with specific sponsor/client/site requirements, including possible vaccination-status or other personal-information disclosures
• Ability to travel frequently, generally 60–80%, with frequent drives to site locations
• Ability to work in office, laboratory, clinical and/or home-office environments
• Potential exposure to biological fluids, infectious organisms, electrical office equipment, and fluctuating/extreme temperatures

• Fully remote work option in Belgium
• Hybrid/office-based work option from the Brussels site
• Standard Monday–Friday work schedule
• Opportunity to work with a global team supporting pharmaceutical and biotechnology clinical trials
• Participation in project publications, tools, process-improvement work, and initiatives
• Extended overnight stays may be included as part of travel requirements