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 c

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