Your new company
Our client is a leading company in the Pharma Sector.
We are seeking a Senior Clinical Research Associate to join our team
You new role
Ensure compliance with client SOPs, study protocols, ICH-GCP and applicable regulations
Train and support investigator site teams on study procedures and systems
Conduct site initiation, monitoring (on-site and remote), and close-out visits
Verify informed consent, study material management, and biological sample handling (if applicable)
Monitor data accuracy and quality by verifying eCRF data against source documents
Review and ensure proper reporting of adverse events (AEs/SAEs)
Maintain investigator site files and manage essential regulatory documentation
Prepare visit reports and follow up on action items with site teams
Provide technical support for eCRF systems and data entry
Maintain regular communication with investigators and project teams
Support patient recruitment and investigator engagement
Manage study archiving and support site billing processes
You will be involved in the IRB submission process (for linguistic support).
Requirements:
Required experience level: Ideally experience in ATTR cardiac amyloidosis and in non-interventional studies. If this is not possible, we search for a confirmed/senior CRA.
At least 10 years experience in the role and functions describe above.
The HQ is based in Italy in Florence.
What to do now
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Candidates of both sexes, after having read the mandatory privacy information on the website, are asked to send their CV. Hays Solutions S.r.l. with sole shareholder. Subject to the direction and coordination of Hays Plc