07 set - Roma
Altro
Work Schedule
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Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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,
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