Senior Clinical Research Associate – Netherlands

🔥 2 hours ago

🇳🇱 Netherlands – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🗣️🇳🇱 Dutch Required

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 2 hours ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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

• 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

🎯 Requirements

• 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

🏖️ Benefits

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

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