Senior Clinical Research Associate, Belgium

🔥 0 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform and coordinate clinical monitoring and site management activities • Conduct remote or on-site visits to assess protocol and regulatory compliance • Manage required documentation, sponsor procedures and monitoring environments • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Maintain audit readiness and collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, including RCA, SDR, SDV and CRF review • Assess investigational product inventory and records • Document observations and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Track trial status and provide progress reports to the Clinical Team Manager • Update and quality-check clinical trial management systems • Participate in investigator meetings and identify potential investigators • Initiate clinical trial sites and ensure trial closeout and retrieval of materials • Ensure essential documents are complete and conduct on-site file reviews • Support project publications, tools, trip report reviews, newsletters and CRA team calls • Facilitate communication among 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 • Travel frequently to site locations, generally 60–80%, with possible overnight stays

🎯 Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • 2+ years of clinical research monitor experience • Previous independent monitoring CRA experience • Valid full driver's licence • Fluency/good language and grammar skills in Dutch, English and French • 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 • Oral and written communication skills • Interpersonal, organizational and time-management skills • Microsoft Office proficiency and ability to learn appropriate software • Presentation skills • Ability to work independently or in a team • Flexibility and adaptability • Ability to comply with sponsor/client/site requirements

🏖️ Benefits

• Fully remote in Belgium or hybrid/office based from the Brussels site • Full-time employment • Standard Monday-Friday work schedule