We are partnering with a leading CRO to recruit both a Clinical Research Associate II and a Senior Clinical Research Associate to support a growing portfolio of clinical studies across Italy. These are home-based positions covering sites primarily within Northern Italy, with an emphasis on high-quality site management and sponsor collaboration.

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This is an excellent opportunity to join a collaborative clinical operations team working on innovative Phase I–IV studies across oncology.

Key Responsibilities

- Independently manage assigned investigative sites throughout the full clinical trial lifecycle.
- Conduct Site Selection Visits (SSVs), Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs) and Close-Out Visits (COVs).
- Ensure studies are conducted in accordance with ICH-GCP,

protocol requirements, SOPs and applicable regulatory guidelines.
- Maintain strong relationships with investigators, site staff and sponsor representatives.
- Perform Source Data Verification (SDV) and Source Data Review (SDR) while ensuring high data quality.
- Identify, document and escalate protocol deviations and study risks where appropriate.
- Review and maintain Investigator Site Files (ISFs), Trial Master Files (TMFs) and essential documentation.
- Support patient recruitment and retention strategies with investigative sites.
- Ensure sites remain inspection and audit ready throughout the duration of the study. xysqume
- Work collaboratively with Clinical Trial Managers, Project Managers and cross-functional teams to ensure successful study delivery.

Clinical Research Associate II / Senior CRA

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Agente di Commercio Monomandatario - Settore Alime

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