Clinical Research Associate Ancona

Clinical Research Associate
Ancona
Marche, Ancona

We are currently looking for a Clinical Research Associate in the clinical trials process for a period of 12+ months in Ancona, Italy.

For this role, the candidate 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 Collate all documents for EC submissions in EU countries.

Perform the EC submission.

Address any questions that may arise from the EC submission.

Establish contracts with local investigators and gather GCP documentation.

Work with translators to translate documents from the local language to English.

Once the EC submission has been approved, transition into routine site monitoring, which will be minimal as there is only one site.

Qualifications Experience as a Clinical Research Associate with 2+ years of independent monitoring experience.

Must have experience monitoring medical device studies.

Must have experience with EC submissions in the local country.

Additional Information: 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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