Thermo Fisher Scientific
Thermo Fisher Scientific
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.

Clinical Trial Coordinator – Argentina (Remote)

Support pharmaceutical and biotechnology clinical trials in Argentina through site activation, regulatory documentation, feasibility activities, eTMF management, and investigator-site coordination.

Descriere

  • Manage assigned clinical trial activities in line with the applicable task matrix
  • Review department, internal, country, and investigator files and record findings
  • Complete assigned work on schedule, within budget, and to required quality standards
  • Provide Activate and eTMF system support while keeping databases current
  • Process Client eTMF documents, complete reviews, distribute communications, and prepare reports
  • Analyze and reconcile study metrics and findings reports
  • Support Investigator Site File and Pharmacy binder materials and manage study supplies
  • Assist with study-specific translations and perform translation quality checks
  • Stay current with SOPs, client instructions, and regulatory requirements
  • Conduct on-site feasibility visits where applicable to Asia Pacific roles
  • Coordinate client and internal meeting schedules
  • Review and track local regulatory documentation
  • Support risk-based monitoring activities
  • Maintain study records, team lists, training requirements, system access, and activity plans
  • Transmit documents to clients and centralized IRB/IEC bodies
  • Keep vendor tracking records up to date
  • Support regulatory submissions and site start-up activities
  • Collect site-selection documents directly from study sites
  • Prepare regulatory compliance review packages
  • Complete Site Interest Plans in CTMS and gather related investigator and site documents
  • Record site communications, follow-ups, and survey responses in real time
  • Check survey data for logical, complete, and relevant responses
  • Work with teammates and clinical personnel on deadlines, site issues, and risks
  • Maintain effective site contact and follow-up plans and escalate concerns or non-compliance
  • Apply local knowledge of site capacity and experience to recommend additional sites
  • Coordinate with Global Investigator Services to resolve investigator questions and maintain account and contact details
  • Contribute to global feasibility processes and related best practices
  • Train new staff on processes and systems
  • Use local knowledge to identify and develop new study sites

Cerințe

  • High school or secondary school diploma, or equivalent, plus a relevant formal academic or vocational qualification
  • A bachelor’s degree is preferred
  • Comparable experience of 0 to 1 year
  • 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 data and systems accurately and efficiently
  • Strong customer focus
  • Flexibility to reprioritize work as needed
  • Working knowledge of applicable country regulations, ICH Good Clinical Practice, and organizational or Client SOPs and WPDs
  • Strong English language and grammar skills, plus local-language proficiency where 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 successfully
  • Effective written and verbal communication skills
  • Sound judgment and decision-making ability
  • Ability to follow project work instructions accurately
  • Good negotiation skills
  • Ability to manage risks and escalate them appropriately
  • Occasional travel may be required
  • Occasional driving to study sites may be required

Beneficii

  • Fully remote work arrangement
  • Standard Monday–Friday schedule

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