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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 Trial Coordinator, Peru (Remote)

Coordinate clinical trial start-up, feasibility, regulatory submissions, documentation, and site communications for a global clinical research organization. Maintain clinical systems, investigator files, study metrics, and related trial records.

PEPeruRemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăCoordonator de studii cliniceGeneral

Descriere

  • Coordinate assigned clinical trial activities in line with task matrices.
  • Review departmental, internal, country, and investigator files and document findings.
  • Complete assigned work on schedule, within budget, and to required quality standards.
  • Support Activate, eTMF, and other clinical trial systems while keeping databases current.
  • Process client eTMF documents, conduct reviews, distribute communications, and prepare reports.
  • Analyze and reconcile study metrics and findings reports and help resolve site-documentation issues.
  • Coordinate Investigator Site File, Pharmacy binder, and non-clinical study supply materials.
  • Support study-specific translation materials and perform translation quality checks.
  • Keep current with SOPs, client instructions, and applicable regulatory requirements.
  • Conduct on-site feasibility visits in Asia Pacific when applicable.
  • Help schedule client and internal meetings and track local regulatory documents.
  • Support risk-based monitoring activities, study documentation, training, system access, and activity plans.
  • Transmit documents to the client and centralized IRB or IEC.
  • Maintain vendor trackers and assist with regulatory submissions.
  • Work with sites to obtain documents required for site selection.
  • Prepare regulatory compliance review packages with the project team.
  • Coordinate internal teams to keep site start-up aligned with the activation critical path.
  • Complete Site Interest Plans in CTMS and collect related documents when required.
  • Record communications, follow-ups, and survey responses in real time.
  • Review survey data for logical, complete, and relevant responses.
  • Work with teammates and clinical personnel on deadlines, site issues, and risks.
  • Maintain site-contact and follow-up plans and escalate concerns or non-compliance.
  • Apply local knowledge of site capacity and experience to recommend additional sites.
  • Work with Global Investigator Services to resolve investigator questions and maintain account and contact details.
  • Contribute to global feasibility strategy and process improvements.
  • Train new personnel on relevant processes and systems.
  • Use local market knowledge to identify and develop new clinical trial sites.

Cerințe

  • High school or secondary school diploma, or equivalent, plus relevant formal academic or vocational training.
  • A bachelor's degree is preferred.
  • Relevant experience equivalent to approximately 0–1 year of required job knowledge, skills, and abilities.
  • Equivalent combinations of appropriate education, training, and directly related experience may be considered.
  • Ability to work independently and collaboratively.
  • Strong organization and attention to detail.
  • Ability to analyze project-specific data and systems accurately and efficiently.
  • Strong customer focus and flexibility to reprioritize work.
  • Working knowledge of applicable country regulations, ICH Good Clinical Practice, organizational or client SOPs, and WPDs.
  • Strong English language and grammar skills, plus local-language proficiency when required.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.
  • Ability to learn and use clinical trial database systems.
  • Ability to complete the organization's clinical training program.
  • Effective oral and written communication, interpersonal, negotiation, judgment, decision-making, risk management, and escalation skills.
  • Ability to follow project work instructions accurately.

Beneficii

  • Fully remote work arrangement.
  • Standard Monday–Friday schedule.
  • Occasional travel may be required.
  • Training and onboarding support.
  • Opportunity to buddy with and train new staff.

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