FSP Bench Clinical Trial Coordinator

Santiago ThermoFisher Scientific

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Trial Coordinator / Clinical Study Administrator - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

What You’ll Do:
- Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
- Collects, assists in preparation, reviews and tracks documents for the application process. Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
- Interfaces with investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.




- Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
- Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
- Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF "Inspection Readiness".
- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
- Contributes to the production and maintenance of study documents, ensuring template and version compliance.
- Creates and/or imports clinical-regulatory documents into the General Electronic Management System, ensuring compliance with the company-approved authoring guide for regulatory documents.
- Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the re

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