Senior Clinical Research Associate – Client-dedicated FSP

🔥 16 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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

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