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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

Principal Clinical Research Associate, FSP — South Korea Remote

Monitor Roche-sponsored clinical trials for a contract research organization, supporting site compliance, accurate data, complete documentation, and trial progress.

KRCoreea de SudRemoteNormă întreagăSeniorLiderLimbă Obligatorie: englezăCercetare clinică
Google Cloud Platform

Descriere

  • Monitor investigator sites using a risk-based approach.
  • Analyze root causes and identify site process failures and corrective or preventive actions.
  • Review source data, source documents, and case report forms during on-site and remote monitoring to ensure data accuracy.
  • Check investigational products through physical inventory and records review.
  • Prepare timely observation reports and letters that meet business writing standards.
  • Escalate deficiencies and issues to clinical management and track them through resolution.
  • Stay in contact with investigative sites between visits to check protocol adherence, issue resolution, and timely data entry.
  • Support investigator payment processes and resolve findings with project team members.
  • Attend investigator meetings and work with the client to identify potential investigators.
  • Initiate trial sites in line with protocols, regulatory requirements, and ICH GCP obligations.
  • Close out trials and retrieve trial materials.
  • Check essential documents for completeness and conduct on-site file reviews.
  • Track trial status and report progress to the Clinical Trial Manager.
  • Maintain study systems, including the Clinical Trial Management System, in line with study conventions.

Cerințe

  • Hold a university degree in a science-related field.
  • Have at least seven years of independent monitoring experience in Phase I–III clinical development.
  • Understand ICH-GCP and KGCP requirements.
  • Be fluent in English.
  • Demonstrate clinical monitoring skills.
  • Understand medical or therapeutic areas and medical terminology.
  • Maintain working knowledge of ICH GCP, applicable regulations, and procedural documents.
  • Apply critical thinking, root cause analysis, and problem-solving skills.
  • Manage risk-based monitoring concepts and processes.
  • Communicate effectively in writing and verbally.
  • Demonstrate customer focus, listening skills, and attention to detail.
  • Organize work and manage time effectively.
  • Build effective working relationships.
  • Adapt flexibly to changing needs.
  • Work effectively both independently and as part of a team.
  • Use Microsoft Office confidently and learn relevant software.

Beneficii

  • Sign-on bonus.

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