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Thermo Fisher Scientific
Thermo Fisher Scientific
Sponsor pentru viza H1BAsistență medicalăIndustria prelucrătoareLogistică
Thermo Fisher Scientific dezvoltă și furnizează tehnologii, produse de laborator și servicii farmaceutice care sprijină cercetarea științifică și asistența medicală. Activitatea sa acoperă cercetarea în domeniul științelor vieții, rezolvarea problemelor analitice, creșterea productivității laboratoarelor, diagnosticarea, precum și dezvoltarea și producția de terapii. Compania își deservește clienții printr-o echipă globală și un portofoliu de mărci care include Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon și PPD. Oportunitățile de carieră includ activitățile științifice, medicale, de producție, logistice și de servicii care susțin aceste oferte.
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Locurile de muncă ale companiei

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.

PLPoloniaRemoteNormă întreagăJuniorNivel mediuLimbă Obligatorie: englezăLimbă Obligatorie: polonezăCercetare clinică
Google Cloud Platform

Descriere

  • 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

Cerințe

  • 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

Beneficii

  • 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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