Freelance Clinical Research Associate (CRA) – Italy
Secteur : Industrie du médicament humain Famille de fonction : Développement clinique
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Description du poste et des missions
Clinact, a Contract Research Organization (CRO) specializing in clinical research, is looking for a Freelance Clinical Research Associate (CRA) based in Italy to support an international Phase IV cardiology study.
As part of the study close-out phase, you will be responsible for monitoring activities and the closure of 6 investigator sites in Italy.
Location: Italy
Contract: Freelance
Duration: Q4 2026
Workload: Approximately 40% (0.4 FTE)
Key Responsibilities
- Conduct monitoring visits and oversee study activities at investigator sites.
- Perform Source Data Verification (SDV) and Source Data Review (SDR), ensuring data accuracy and consistency with the EDC system.
- Ensure compliance with the study protocol, ICH-GCP guidelines, and applicable Italian regulatory requirements.
- Follow up on outstanding queries, missing data, and any identified discrepancies.
- Review and maintain Investigator Site File (ISF) and Trial Master File (TMF) documentation, ensuring completeness and accuracy.
- Coordinate and perform study close-out activities across 6 investigator sites in Italy.
Profil souhaité
Profile
- Degree in Life Sciences or a related scientific field.
- Proven experience as a Clinical Research Associate, with strong expertise in clinical trial monitoring and site close-out activities.
- Good knowledge of ICH-GCP guidelines and Italian clinical research regulations.
- Fluency in Italian and professional proficiency in English.
- Ability to work independently, with strong organizational skills and attention to detail.
- Based in Italy and operating as a freelancer.
About Clinact
Clinact is a Contract Research Organization (CRO) specializing in clinical research. As part of the MultiHealth Group, Clinact provides expertise and support to pharmaceutical and healthcare companies throughout their clinical development projects.
Please send us your CV and availability, and our recruitment team will get in touch with you.
