22 set - Roma
Barrington James
I am looking to connect with freelance clinical research associates who have experience in the monitoring of cardiovascular + medical device studies. You will be taking ownership of monitoring a single site, joining an already established team based out of Rome Italy, on a 12-month tempo parziale contract.
Key responsibilities:
- Experience CRA with expertise in monitoring medical device clinical studies.
- Conduct Source Data Verification and Source Data Review, ensuring data accuracy, and consistency with the EDC system.
- Ensure compliance with study protocols, ICH-GCP guidelines, and applicable Italian regulatory requirements.
- Manage and reconcile Trial Master File and Investigator Site File documentation to ensure accurate and complete site-level records.
Key requirements:
- Fluent in Italian and with professional working proficiency in English.
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