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Clinical Trial Coordinator

hace 2 meses

Xico, México Thermo Fisher Scientific A tiempo completo
Job Summary

We are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team at Thermo Fisher Scientific. As a Clinical Trial Coordinator, you will play a critical role in the success of our clinical trials by providing administrative and technical support to our project teams.

Key Responsibilities
  • Coordinate and oversee trial activities, ensuring timely completion and high-quality standards.
  • Perform department, internal, country, and investigator file reviews, documenting findings in appropriate systems.
  • Ensure allocated tasks are performed on time, within budget, and to a high standard, proactively communicating any risks to project leads.
  • Support the maintenance of study-specific documentation and systems, including study team lists, tracking of project-specific training requirements, system access management, and tracking of project-level activity plans.
  • Provide system support, including GoBalto and eTMF.
  • Support Risk-Based Monitoring (RBM) activities.
  • Perform administrative tasks, including timely processing of documents sent to clients, performing eTMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
  • Support scheduling of client and/or internal meetings.
  • Review and track local regulatory documents.
  • Transmit documents to clients and centralized IRB/IEC.
  • Analyze and reconcile study metrics and findings reports, assisting with clarification and resolution of findings related to site documentation.
  • Maintain vendor trackers.
  • Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  • Assist with study-specific translation materials and translation QC upon request.
Requirements
  • High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.
  • Bachelor's degree preferred.
  • Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
  • In some cases, an equivalency consisting of a combination of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.