Freelance CRA / Italy

Barrington James Limited; Roma; In loco; EUR 55.000 - 83.000; Part-time

Descrizione del lavoro

Barrington James Limited is seeking a freelance Clinical Research Associate to monitor cardiovascular medical device studies in Rome, Italy. This is a 12-month, part-time contract with ownership of a single site and an established team.

The role requires fluency in Italian and professional proficiency in English, a track record in Source Data Verification, and strong attention to ICH-GCP and regulatory standards.

Competenze

• Experience monitoring cardiovascular medical device studies.
• Source Data Verification and Source Data Review per study protocol and data specs.
• Knowledge of ICH-GCP guidelines and Italian regulatory requirements.
• Experience managing Trial Master File and Investigator Site File documentation.

Mansioni

• Monitor a single site in Rome.
• Ensure data accuracy and alignment with the EDC system.
• Maintain TMF and Investigator Site File documentation.
• Ensure compliance with study protocols and regulatory requirements.

Conoscenze

CRA monitoring

Medical devices

Source Data Verification

Strumenti

EDC system

Descrizione del lavoro

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.