10 set - Balgano
Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation
What You’ll Do
Clinical Trial & Documentation Support
- Coordinate and complete assigned clinical trial activities in accordance with the study task matrix.
- Perform Country and Investigator file reviews and document findings in the appropriate systems.
- Support audit and inspection readiness by ensuring study files are reviewed according to applicable schedules and procedures.
- Ensure assigned activities are completed on time and to a high-quality standard, proactively communicating potential risks to project leads.
- Process and maintain clinical trial documentation within the electronic Trial Master File (eTMF).
- Review eTMF documentation and support the resolution of missing, incomplete, or outstanding documentation.
- Analyze findings reports and assist with the clarification and resolution of site documentation findings.
- Support the preparation, compilation, and distribution of Investigator Site Files (ISFs),
pharmacy binders, and study supplies.
- Assist with study-specific translations and translation quality control, as required.
Site Activation & Regulatory Support
- Provide administrative support for site activation and start-up activities.
- Work with internal teams to help ensure site start-up activities remain aligned with the site’s activation critical path and project timelines.
- Support regulatory submissions and the tracking of local regulatory documentation.
- Transmit required documentation to clients and centralized Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), as applicable.
- Maintain accurate and timely records of site communications, contact attempts, follow-ups, and survey responses.
- Review survey information to help ensure responses are complete, accurate, and relevant.
- Support effective site follow-up plans and escalate concerns or potential risks ap
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