Clinical Research Associate

3 ore fa

San Miniato, Italia Hays A tempo pieno

Your new companyOur client is a leading company in the Pharma Sector.We are seeking a Senior Clinical Research Associate to join our teamYou new roleEnsure compliance with client SOPs, study protocols, ICH-GCP and applicable regulationsTrain and support investigator site teams on study procedures and systemsConduct site initiation, monitoring (on-site and remote), and close-out visitsVerify informed consent, study material management, and biological sample handling (if applicable)Monitor data accuracy and quality by verifying eCRF data against source documentsReview and ensure proper reporting of adverse events (AEs/SAEs)Maintain investigator site files and manage essential regulatory documentationPrepare visit reports and follow up on action items with site teamsProvide technical support for eCRF systems and data entryMaintain regular communication with investigators and project teamsSupport patient recruitment and investigator engagementManage study archiving and support site billing processesYou 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 nowIf you are interested in this opportunity, click on "Apply now". If this opportunity is not in line with your expectations, but you are looking for a new job, visit our website to discover new ones.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

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