Clinical Trial Coordinator FSP LATAM

hace 2 semanas

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 in FSP LATAM. 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 standards.
  • Perform department, internal, country, and investigator file reviews, documenting findings in relevant systems.
  • Ensure allocated tasks are performed on time, within budget, and to a high standard, proactively communicating any risks to project leads.
  • Provide system support and ensure system databases are current.
  • Perform administrative tasks, including processing documents, performing reviews, distributing communications, and providing 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 (Asia Pac only) where applicable.
  • 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, harnessing this knowledge base when performing local tiering of 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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