Clinical Research Associate II
Pubblicato il 31-08-2026 - Barrington James in Roma
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.
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.
Work collaboratively with Clinical Trial Managers, Project Managers and cross-functional teams to ensure successful study delivery.