Clinical Trial Coordinator FSP LATAM

hace 1 semana

Bogotá, Bogotá D.E., Colombia Thermo Fisher Scientific A tiempo completo
Job Summary

We are seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team. The successful candidate will provide administrative and technical support to our project team, ensuring the smooth execution of clinical trials.

Key Responsibilities
  • Coordinate and oversee trial activities, ensuring timely completion and high-quality results.
  • Perform department, internal, country, and investigator file reviews, documenting findings in relevant systems.
  • Ensure allocated tasks are completed on time, within budget, and to a high standard, proactively communicating any risks to project leads.
  • Provide system support and ensure system databases are always current.
  • Perform administrative tasks, including processing documents, performing reviews, distributing communications, and providing documents and reports to internal team members.
  • Analyze and reconcile study metrics and findings reports, assisting with clarification and resolution of findings related to site documentation.
  • 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.
  • Maintain knowledge of and understand SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Conduct on-site feasibility visits, as required.
  • Support scheduling of client and/or internal meetings.
  • Review and track local regulatory documents.
  • Provide system support and support RBM activities.
  • Maintain 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 in relevant 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, ensuring site start-up activities within the site activation critical path are aligned.
  • Complete the 'Site Interest Plan' in CTMS and collection and delivery of associated documents from investigators and site personnel.
  • Document in real-time all communication, attempts, and follow-up associated with site contact and survey responses.
  • Support the review of survey data to ensure responses are logical, complete, and reflective of the question asked.
  • Work in collaboration with teammates to achieve targeted deadlines for assigned projects, communicating with the team and appropriate clinical personnel regarding site issues and risks.
  • Ensure an efficient, effective plan is in place for site contact and follow-up, ensuring compliance with the plan and escalating concerns/non-compliance to management.
  • Act as the local expert regarding site capacity and experience, working with key local personnel to gather knowledge base and recommend additional sites.
  • Liaise with Global Investigator Services to resolve investigator queries in real-time and maintain 'accounts and contact' information.
  • Contribute to the development and roll-out of global strategic feasibility processes and best practices.
  • Train new personnel in processes and systems.
  • Utilize local knowledge to contribute to the identification and development of new sites.

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