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Thermo Fisher Scientific
Thermo Fisher Scientific
H1B Visa SponsorHealthcareLogisticsManufacturing
Thermo Fisher Scientific develops and delivers technologies, laboratory products, and pharmaceutical services that support scientific research and healthcare. Its work spans life sciences research, analytical problem-solving, laboratory productivity, diagnostics, and the development and manufacturing of therapies. The company serves customers through a global team and a portfolio of brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. Its careers encompass the scientific, healthcare, manufacturing, logistics, and service operations behind these offerings.
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Clinical Research Associate I/II - Oncology | Poland Remote

Monitor oncology clinical trials across Poland for a global research organization. Support site compliance, data quality, essential documentation, and inspection readiness through remote and on-site activities.

PLPolandRemoteFull-timeJuniorMiddleEnglish RequiredPolish RequiredClinical Research
Google Cloud Platform

Description

  • Coordinate clinical monitoring and site management activities
  • Conduct remote and on-site visits to evaluate protocol and regulatory compliance
  • Manage required documentation, sponsor procedures, and monitoring environments
  • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
  • Monitor investigator sites using risk-based monitoring methods
  • Use root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective or preventive actions
  • Verify data accuracy through source document review, source data verification, and CRF review during remote and on-site monitoring
  • Assess investigational product inventory and related records
  • Record observations in reports and letters using approved business-writing standards
  • Escalate deficiencies and issues to clinical management and track them through resolution
  • Maintain communication with investigative sites between monitoring visits
  • Perform monitoring activities according to approved monitoring plans
  • Support investigator payment processes and investigator meetings
  • Identify potential investigators in collaboration with client companies
  • Initiate clinical trial sites and confirm protocol, regulatory, and ICH-GCP compliance
  • Complete trial closeout activities and retrieve trial materials
  • Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations
  • Conduct on-site file reviews
  • Track trial status and provide progress updates
  • Keep study systems, including Clinical Trial Management Systems, accurate and current
  • Coordinate communication among investigative sites, client companies, and internal project teams
  • Respond to company, client, and regulatory requirements, audits, and inspections
  • Complete expense reports, timesheets, and other administrative tasks
  • Support project publications and tools
  • Contribute ideas to project work and process-improvement initiatives

Requirements

  • Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or an equivalent relevant academic or vocational qualification
  • At least minimal clinical monitoring experience comparable to two years in a clinical environment, including clinical trials, medical terminology, medical research, clinical research, health care, or health sciences, with formal training in medical terminology and anatomy
  • Clinical monitoring experience in oncology
  • Valid driver’s license where applicable
  • Equivalent qualifications may be considered through a combination of appropriate education, training, and directly related experience
  • Basic knowledge of medical or therapeutic areas and medical terminology
  • Ability to obtain and maintain working knowledge of ICH-GCP requirements, applicable regulations, and procedural documents
  • Strong spoken and written communication skills, including communication with medical personnel
  • Effective interpersonal skills
  • Customer focus, active listening, attention to detail, and ability to identify underlying customer issues
  • Strong organization and time-management skills
  • Flexibility and adaptability
  • Well-developed critical-thinking, root-cause analysis, and problem-solving skills
  • Ability to manage risk-based monitoring concepts and processes
  • Ability to work independently and collaboratively
  • Solid Microsoft Office knowledge and ability to learn relevant software
  • Good English and Polish language and grammar skills
  • Willingness to drive frequently to site locations and travel frequently, generally 60–80%, including possible extended overnight stays
  • Ability to work with occasional exposure to biological fluids, infectious organisms, electrical office equipment, and fluctuating or extreme temperatures
  • Ability to use required personal protective equipment, including protective eyewear, garments, and gloves

Benefits

  • Fully remote work arrangement
  • Full-time employment
  • Standard Monday-to-Friday schedule

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