Clinical Trial Coordinator

hace 2 semanas

Ciudad de México, Ciudad de 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. The successful candidate will be responsible for coordinating and overseeing various aspects of clinical trials, ensuring timely and efficient execution of project activities.

Key Responsibilities
  • Coordinate and oversee trial activities, including department, internal, country, and investigator file reviews.
  • Ensure allocated tasks are performed on time, within budget, and to a high-quality standard.
  • Provide system support and ensure system databases are always current.
  • Perform administrative tasks, including processing documents, performing eTMF reviews, and distributing mass mailings.
  • Analyze and reconcile study metrics and findings reports.
  • Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials.
  • Support study-specific translation materials and translation QC.
  • Maintain knowledge of and understand SOPs, client SOPs/directives, and current regulatory guidelines.
  • Conduct on-site feasibility visits (Asia Pac only).
  • Support scheduling of client and/or internal meetings.
  • Review and track local regulatory documents.
  • Provide system support and support RBM activities.
  • Support the maintenance of study-specific documentation and systems.
  • Transmit documents to client and centralized IRB/IEC.
  • Maintain vendor trackers.
  • Support start-up team in Regulatory submissions.
  • Work directly with sites to obtain documents related to site selection.
  • Assist the project team with the preparation of regulatory compliance review packages.
  • Provide support as needed to coordinate with internal departments.
Requirements
  • High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification.
  • Bachelor's degree preferred.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
  • Adaptability to work in various support areas (finance, regulatory, TMF, logistics).
  • Excellent organizational and teamwork skills.
  • Good level of English (oral and written).
  • Effective communication skills.
  • Ability to work in a team or independently as required.
  • Good organizational skills and strong attention to detail.
  • Demonstrated ability to effectively analyze project-specific data/systems.
  • Strong customer focus.
  • Flexibility to reprioritize workload to meet changing project timelines.
  • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs.
  • Good English language and grammar skills and proficient local language skills as needed.
  • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
  • Ability to successfully complete the organization's clinical training program.
  • Self-motivated, positive attitude and good interpersonal skills.
  • Effective oral and written communication skills.
  • Good interpersonal skills.
  • Essential judgment and decision-making skills.
  • Capable of accurately following project work instructions.
  • Good negotiation skills.
  • Independent thinker.
  • Ability to manage risk and perform risk escalation appropriately.
Working Conditions and Environment
  • Work is performed in an office/laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
  • Occasional drives to site locations. Potential Occasional travel required.

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