Senior Clinical Research Associate – Sponsor: Roche

🔥 3 hours ago

🇰🇷 South Korea – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.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

🧬 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

• Monitor investigator sites using a risk-based monitoring approach • Apply 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 CRF review during on-site and remote monitoring • Assess investigational product through physical inventory and records review • Document observations in reports and letters according to timelines and business writing standards • Escalate deficiencies and issues to clinical management and follow them through resolution • Maintain contact with investigative sites between monitoring visits to confirm protocol compliance, issue resolution, and timely data recording • Participate in investigator payment processes and collaborate on findings resolution • Participate in investigator meetings and identify potential qualified investigators with the client • Initiate clinical trial sites according to procedures and ensure protocol, regulatory, and ICH-GCP compliance • Perform trial closeout and retrieve trial materials • Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations • Conduct on-site file reviews according to project specifications • Provide trial status tracking and progress updates to the Clinical Team Manager • Update study systems, including Clinical Trial Management Systems, according to study conventions

🎯 Requirements

• University degree in a science-related field • At least 5 years of independent monitoring experience in clinical development phases I–III • Understanding of ICH-GCP and KGCP requirements • Fluency in English • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge 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 • Good oral and written communication skills • Customer focus, listening skills, attention to detail, and ability to identify underlying issues • Organizational and time management skills • Effective interpersonal skills • Flexibility and adaptability • Ability to work independently and in a team • Solid Microsoft Office knowledge and ability to learn appropriate software

🏖️ Benefits

• Sign-on bonus • Fully remote work arrangement • Standard Monday–Friday work schedule

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