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.What to do nowIf you are interested in this opportunity, click on\ "Apply now\".
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Hays Solutions S.R.L. with sole shareholder.
Subject to the direction and coordination of Hays Plc