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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 (Multiple Levels) – Poland Remote

Clinical Research Associate roles supporting investigator-site monitoring and clinical trial compliance for Thermo Fisher Scientific’s PPD research services. The position includes remote and on-site visits across Poland.

PLPolandRemoteFull-timeJuniorMiddleEnglish RequiredPolish RequiredClinical Research
Google Cloud Platform

Description

  • Coordinate clinical monitoring and site management activities
  • Perform remote and on-site visits to evaluate protocol and regulatory compliance
  • Maintain required clinical trial records and follow sponsor procedures
  • Support site processes in accordance with protocols, ICH-GCP, regulations and SOPs
  • Apply risk-based monitoring methods at investigator sites
  • Use root cause analysis, critical thinking and problem-solving to identify failures and define corrective and preventive actions
  • Verify data accuracy through source document review, source data verification and CRF review
  • Review investigational product inventories and related records
  • Record monitoring observations in reports and correspondence
  • Escalate deficiencies and track issues through resolution
  • Stay in contact with investigative sites between monitoring visits
  • Complete monitoring activities in line with the approved monitoring plan
  • Support investigator payments and investigator meetings
  • Identify potential investigators and help initiate clinical trial sites
  • Complete trial closeout activities and recover trial materials
  • Confirm essential documents are complete and perform on-site file reviews
  • Monitor trial status and provide progress reports
  • Keep study systems complete and accurate, including Clinical Trial Management Systems
  • Coordinate communication between sites, clients and internal project teams
  • Address company, client and regulatory requests, audits and inspections
  • Submit expense reports and timesheets
  • Support project publications, tools and process improvement initiatives

Requirements

  • Bachelor’s degree in a life sciences-related discipline
  • At least one year of clinical monitoring experience in a clinical setting, including clinical trials, medical terminology, medical research, clinical research or health care
  • Relevant health sciences experience with formal medical terminology and anatomy training may be considered
  • Valid driver’s license where applicable
  • Equivalent combinations of relevant education, training and directly related experience may be considered
  • Foundational knowledge of medical or therapeutic areas and medical terminology
  • Ability to develop and maintain working knowledge of ICH-GCP, applicable regulations and procedural documents
  • Strong verbal and written communication skills
  • Effective interpersonal skills
  • Customer orientation, attentive listening and careful attention to detail
  • Strong organization and time-management abilities
  • Willingness to adapt and work flexibly
  • Critical thinking, root cause analysis and problem-solving capabilities
  • Ability to manage risk-based monitoring concepts and processes
  • Capacity to work independently and collaboratively
  • Working knowledge of Microsoft Office and ability to learn relevant software
  • Strong English and Polish language and grammar skills
  • Ability to travel more than 75% of the time

Benefits

  • Competitive compensation
  • Recognized learning and development program
  • Flexible approach to working
  • Support for work-life balance
  • Collaborative work environment
  • Opportunities to exchange expertise and learn with colleagues
  • Health and well-being benefits package

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