Clinical Trial Coordinator Fsp Latam

hace 1 semana

Xico, México Thermo Fisher Scientific A tiempo completo

**Job Summary**

Thermo Fisher Scientific is seeking a highly organized and detail-oriented Clinical Trial Coordinator to join our team. As a Clinical Trial Coordinator, you will play a critical role in supporting the project team by providing administrative and technical support.

**Key Responsibilities**

  • Support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document.
  • Provide administrative support for site activation activities.
  • Aid the development of the critical path for site activation within assigned projects in support of rapid site activations.
  • Represent CRG personnel and utilize local knowledge to develop and review site lists that are suitable for the strategic needs of feasibility activities.
  • Act as a buddy during onboarding phase and provide training to new staff as needed.
  • Coordinate, oversee and complete functions on assigned trial(s) activities as detailed on the task matrix.
  • Perform department, Internal, Country and Investigator file reviews as assigned, and document findings in appropriate system(s).
  • Ensure allocated tasks are performed on time, within budget and to a high-quality standard.
  • Proactively communicate any risks to project leads.
  • Provide system support (i.e., Activate & eTMF) and ensure system databases are always current.
  • Perform administrative tasks on assigned trials, including timely processing of documents sent to Client (e)TMF as assigned.
  • Analyze and reconcile study metrics and findings reports.
  • Assist 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 understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Conduct on-site feasibility visits (Asia Pac only).
  • Support scheduling of client and/or internal meetings.
  • Review and track of local regulatory documents.
  • Provide system support (i.e., Activate & eTMF).
  • 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.
  • 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.
  • Communicate 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.
  • Escalate concerns/non-compliance to management.
  • Act as the local expert regarding site capacity and experience.
  • Liaise with Global Investigator Services to resolve investigator queries in real time.
  • 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.

**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).

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