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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 – Rio de Janeiro (Hybrid)

Coordinate clinical trial operations in support of pharmaceutical and biotechnology studies at a global research services organization. Manage trial documentation, regulatory materials, study systems, performance metrics, and site supplies.

BRBraziliaHibridNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăCoordonator de studii cliniceGeneral

Descriere

  • Provide administrative and technical assistance to the Project Team
  • Coordinate project activities and may act as a study lead
  • Serve as a liaison between project functions
  • Support onboarding as a buddy and train new staff when needed
  • Contribute to departmental and cross-functional process improvement efforts
  • Coordinate, monitor, and complete assigned trial activities in line with the task matrix
  • Review departmental, internal, country, and investigator files and document findings
  • Complete assigned work on schedule, within budget, and according to quality standards
  • Escalate project risks to project leads and the line manager
  • Maintain study records, team lists, training trackers, system access, and project plans
  • Keep the electronic Trial Master File (eTMF) current
  • Support GoBalto, eTMF, and risk-based monitoring activities
  • Handle administrative trial work, including document processing, eTMF reviews, mailings, communications, and reporting
  • Arrange client and internal meetings and prepare minutes
  • Review and monitor local regulatory documentation
  • Send documents to the client and centralized IRB/IEC
  • Analyze and reconcile study metrics and findings reports
  • Help resolve documentation findings at study sites
  • Maintain vendor tracking records
  • Coordinate Investigator Site File and Pharmacy binder materials, along with non-clinical study supplies for sites
  • Support study-specific translation materials and perform translation quality control
  • Attend kick-off meetings and record notes when required

Cerințe

  • High school or secondary school diploma, or equivalent, plus relevant formal academic or vocational training
  • At least four years of comparable experience demonstrating the knowledge, skills, and abilities required for the role
  • Bachelor’s degree preferred
  • Ability to work independently or collaboratively as needed
  • Strong organization and attention to detail, with the ability to manage multiple tasks efficiently
  • Ability to analyze project-specific data and systems for accuracy and efficiency
  • Strong customer-service orientation
  • Flexibility to reprioritize work and adapt to changing project timelines
  • Working knowledge of applicable country regulations, ICH Good Clinical Practice, and organizational, client, and WPD procedures
  • Excellent English and grammar skills, with local-language proficiency where required
  • Good presentation abilities
  • Advanced computer skills, including MS Office proficiency and the ability to learn clinical trial database systems
  • Ability to complete the PPD clinical training program successfully
  • Self-motivated approach, positive attitude, and strong interpersonal skills
  • Ability to work in office, laboratory, clinical, and/or home-office settings
  • Ability to drive to site locations occasionally and travel when required

Beneficii

  • Standard Monday-to-Friday schedule
  • Hybrid work arrangement
  • Occasional travel may be required
  • Professional training through the PPD clinical training program

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