Clinical Research Associate
We are currently looking for a Clinical Research Associate in the clinical trials process for a period of 12+ Months in Torino, Italy.
For this role, they will be responsible for overseeing and monitoring clinical trials to ensure that they are conducted in compliance with regulatory requirements, good clinical practices (GCP), and the trial protocol.
Responsibilities CRAs in EU countries to collate all documents for EC submissions.
Perform the EC submission.
Respond to any questions that may arise from the EC submission.
Establish contracts with local investigators and gather GCP documentation.
Work with translators to translate from the local language to English.
Once the EC submission has been approved, the hours will reduce slightly and will move into routine site monitoring, but this will not be high as there is only 1 site.
Qualifications Experience as a Clinical Research Associate with 2+ years of independent monitoring experience.
Must have some experience monitoring medical device studies.
Must have experience with EC submissions in the local country.
Additional Notes: One visit per month on site.
8-10 hours a week (average of 2 hours a week).
Experience in monitoring medical devices and EC submission is a MUST.
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