Freelance CRA
1 giorno fa
Latina, Lazio, Italia
Barrington James Limited
Tempo pieno
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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 part time 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. #J-18808-Ljbffr
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. #J-18808-Ljbffr