Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
We are looking for a Clinical Research Associate I (CRA I) to join our clinical operations team in Italy.
As a CRA I, you will perform and coordinate clinical monitoring and site management activities across investigator sites. Working through a combination of on-site and remote monitoring, you will help ensure that clinical trials are conducted in accordance with the approved protocol, ICH-GCP, applicable regulatory requirements and standard operating procedures (SOPs).
You will act as a key point of contact for investigational sites, helping safeguard participants’ rights, safety and well-being while supporting the quality, integrity and reliability of clinical trial data.
What you’ll do
Monitor investigator sites using a risk-based monitoring approach, conducting on-site and remote monitoring activities in accordance with the approved monitoring plan.
Perform source data review (SDR), source data verification (SDV) and case report form (CRF) review, as applicable,



to support data quality and integrity.
Assess site compliance with the study protocol, ICH-GCP, applicable regulations, SOPs and project-specific requirements.
Apply critical thinking, root cause analysis and problem-solving techniques to identify site-level issues and support appropriate corrective and preventive actions.
Review investigational product accountability through physical inventory and associated records, as required.
Document monitoring observations clearly and accurately in reports and follow-up correspondence within required timelines.
Identify and escalate significant issues and deficiencies to clinical management and follow actions through to resolution.
Maintain regular communication with investigational sites between monitoring visits, as required, to support protocol compliance, timely data entry and resolution of outstanding issues.
Conduct site initiation, routine monitoring and close-out activities i

📌 CRA (Level I) (Milano)
🏢 Thermo Fisher Scientific
📍 Milano