Clinical Trial Operations Specialist

hace 2 meses


Santiago, Metropolitana, Chile Thermo Fisher Scientific A tiempo completo
Key Responsibilities:

• Perform department, internal, country, and investigator file reviews as assigned, documenting findings in the appropriate system.
• Ensure allocated tasks are completed on time, within budget, and to a high-quality standard.
• Proactively communicate any project risks to project leads.

Supporting Study Operations:
• Maintain study-specific documentation and systems, including study team lists, project-specific training requirements, system access management, and tracking of project-level activity plans in the appropriate system.
• Provide system support (GoBalto & eTMF).
• Support Risk-Based Monitoring (RBM) activities.
• Perform administrative tasks on assigned trials, including timely processing of documents sent to clients (e)TMF, performing (e)TMF reviews, mass mailings, and communications as needed, and 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.
• Assist 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.

Additional Responsibilities:
• Provide administrative support for site-initiated amendments and site supply shipments.
• Manage couriers.
• Support Clinical Research Associates (CRAs) in visit preparation.
• Support Clinical Trial Managers/Project Managers (CTMs/PMs) in country project-related expenditures.
• Assist in translation and translation QC.
• Distribute country and site-level communications.
• Create and maintain investigator lists.
• QC of country and site-level documents.
• Submission of complete country and site-level documents to eTMF and related tracking in CTMS.
• Perform document tracking in CTMS, verify appropriate country or site-level activity plans are applied, update country-level activities/documents for amendments.
• Compile and distribute Investigator Site File (ISF) and Pharmacy binder to site prior to SIV.
• Review eTMF reports and Preclarus dashboards to identify country and site-level essential documents statuses.
• Follow up on outstanding/missing study documents to be sent to site.
• Forward "wet ink" documents retrieved from sites.


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