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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 - Remote, Mexico

Support clinical trial site activation, feasibility, regulatory submissions, documentation, and study systems from a remote role based in Mexico. Provide administrative and technical coordination for pharmaceutical and biotechnology research programs.

MXMexicRemoteNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăCoordonator de studii cliniceGeneral

Descriere

  • Provide administrative and technical support to the Project Team
  • Support audit readiness through scheduled file reviews aligned with SOPs and department guidance
  • Provide administrative support for site activation activities
  • Help develop critical paths for site activation
  • Develop and review feasibility site lists and provide local input on site tiering
  • Coordinate, oversee, and complete assigned trial activities according to the task matrix
  • Conduct department, internal, country, and investigator file reviews and document findings
  • Complete assigned work on schedule, within budget, and to required quality standards
  • Support Activate and eTMF systems and maintain current databases
  • Process client eTMF documents, conduct eTMF reviews, distribute communications, and provide documents and reports
  • Analyze and reconcile study metrics and findings reports
  • Assist with Investigator Site File and pharmacy binder materials and non-clinical study supplies
  • Support translation materials and translation quality-control activities
  • Maintain current knowledge of SOPs, client directives, and regulatory guidelines
  • Support client and internal meeting scheduling and local regulatory document tracking
  • Support RBM activities and maintain study documentation and systems
  • Transmit documents to clients and centralized IRB/IEC bodies
  • Maintain vendor trackers
  • Support regulatory submissions and collect site-selection documents
  • Prepare regulatory compliance review packages
  • Coordinate with internal departments to align site start-up activities
  • Complete Site Interest Plans in CTMS and collect related investigator and site documents
  • Record site communications, follow-ups, and survey responses in real time
  • Review survey data for logical, complete, and relevant responses
  • Collaborate with teammates and clinical personnel on site issues and risks
  • Maintain site contact and follow-up plans and escalate concerns or non-compliance
  • Provide local expertise on site capacity and experience and recommend additional sites
  • Work with Global Investigator Services to resolve investigator queries and maintain account and contact information
  • Contribute to global strategic feasibility processes and best practices
  • Train new personnel on processes and systems
  • Use local knowledge to identify and develop new sites

Cerințe

  • High school or secondary school diploma or equivalent, plus a relevant formal academic or vocational qualification
  • Bachelor's degree preferred
  • Previous experience comparable to 0 to 1 year
  • Equivalent education, training, or directly related experience may be considered
  • Ability to work independently and collaboratively
  • Strong organizational skills and attention to detail
  • Ability to manage multiple tasks efficiently and effectively
  • Ability to analyze project-specific data and systems accurately and efficiently
  • Strong customer focus
  • Flexibility to reprioritize work as project timelines change
  • Working knowledge of applicable country regulations, ICH Good Clinical Practices, organizational and client SOPs, and WPDs
  • Good English language and grammar skills, with proficient local-language skills as needed
  • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint
  • Ability to learn and master clinical trial database systems
  • Ability to complete the organization's clinical training program
  • Effective oral and written communication skills
  • Sound judgment and decision-making skills
  • Ability to follow project work instructions accurately
  • Good negotiation skills
  • Ability to manage risk and escalate risks appropriately

Beneficii

  • Fully remote work arrangement
  • Standard Monday-Friday work schedule

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