FSP Clinical Research Associate I/Clinical Research Associate II

🔥 24 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 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-specific procedures and guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Protect subjects' rights and well-being and ensure data reliability and audit readiness • Develop collaborative relationships with investigational sites • Monitor investigator sites using risk-based monitoring, root cause analysis, critical thinking, and problem-solving • 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 investigative sites between monitoring visits • Conduct monitoring according to approved monitoring plans and participate in investigator payment processes • Participate in investigator meetings and help identify qualified investigators and sites • Initiate clinical trial sites and perform trial close-out and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Track trial status, provide progress reports, and maintain study systems such as CTMS • Facilitate communication among investigative sites, the client company, and internal project teams • Respond to company, client, and regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Assist with project publications and tools and contribute to process-improvement initiatives

🎯 Requirements

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Approximately 2 years of clinical monitoring experience in a clinical environment, clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy • Monitoring experience with Oncology • Valid driver's license where applicable • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered • Basic medical/therapeutic area knowledge and understanding of medical terminology • Working knowledge of ICH GCPs, applicable regulations, and procedural documents, or ability to attain and maintain it • Good oral and written communication skills • Good interpersonal skills • Customer focus, listening skills, attention to detail, and ability to identify underlying customer issues • Good organizational and time management skills • Flexibility and adaptability • Critical thinking, root cause analysis, and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Ability to work independently or as part of a team • Solid knowledge of Microsoft Office and ability to learn appropriate software • Good English and Polish language and grammar skills • Ability to travel frequently, generally 60–80%, including potential extended overnight stays • Ability to work in office, laboratory, clinical, and/or home office environments and use required personal protective equipment

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Opportunity to work with global teams and leading pharmaceutical and biotechnology companies • Professional exposure to clinical trials across multiple sponsors and monitoring environments • Personal protective equipment provided/required for applicable work environments

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