CRA II

🔥 9 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🧪 Clinical Research

👻 Ghost score 15%

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

• 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/monitoring-environment procedures • 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 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 • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with sites between monitoring visits to verify protocol compliance, issue resolution and timely data recording • Participate in investigator payments, meetings and site identification • Initiate clinical trial sites and perform trial closeout and retrieval of materials • Ensure essential documents are complete and conduct on-site file reviews • Provide trial status and progress reports to the Clinical Team Manager • Update study systems such as the Clinical Trial Management System • Facilitate communication among investigative sites, the client company and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Assist with project publications, tools and process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • At least 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship • Valid driver's license where applicable • Proven clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Working knowledge of ICH GCPs, applicable regulations and procedural documents • Risk-Based Monitoring concepts and processes • Root cause analysis and problem-solving skills • Good oral and written communication skills, including communication with medical personnel • Good organizational and time management skills • Effective interpersonal skills and attention to detail • Ability to remain flexible and adaptable • Ability to work independently or in a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English language and grammar skills • Good presentation skills • Willingness and ability to travel frequently, generally 60–80%, including possible extended overnight stays • Ability to work in office, laboratory, clinical and/or home office environments • Ability to use required personal protective equipment

🏖️ Benefits

• Fully remote work mode • Standard Monday-Friday work schedule • Frequent travel expenses may be covered (not explicitly stated) • Personal protective equipment such as protective eyewear, garments and gloves

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