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Clinical Research Associate (CRA)
Clinical OperationsItaly (Remote)Full TimeTravel up to 75%
About the Role
Pi Health is building FICS, an AI operating system for clinical research that consolidates the entire clinical trial lifecycle into one unified system. As a Clinical Research Associate, you will oversee trial sites across multiple European countries, ensuring the safety of subjects and the integrity of the data we collect.
You will conduct the full range of monitoring visits, evaluate site performance, and escalate issues that affect subject safety or data quality — all while helping us prove out a new model for running trials faster and more efficiently.
What You'll Do
- Conduct site qualification, initiation, monitoring, management, and closeout visits across assigned sites
- Evaluate site performance, identify factors affecting subject safety and data integrity, and escalate serious issues promptly
- Verify informed consent procedures and perform source document review
- Assess site compliance with data entry protocols and review investigational product inventory and storage
- Maintain the accuracy of the Investigator Site File and prepare regional metrics and trip reports
- Support audit readiness, investigator meetings, site staff training, and regulatory compliance
Qualifications
- Minimum 2 years of Clinical Monitor / CRA experience in biotech, pharma, or a CRO
- Strong understanding of clinical trial processes and ICH GCP guidelines
- Report writing capability and the ability to comprehend clinical research documents
- Excellent organizational and communication abilities
- Proficiency with Microsoft Office and project management tools
Nice to Have
- Understanding of EDC, IRT, CTMS, and TMF platforms
Details
- Travel: up to 75% across Spain, Italy, and the UK
- Full time
How to Apply
Send your resume and a brief note about your clinical monitoring experience.
Apply NowPi Health is an equal opportunity employer.