Freelance CRA – Italy (Phase IV Cardiology) Close-Out

Taleez; Milano; On-site; EUR 67,000 - 100,000; Full time

Job summary

Clinact, a CRO, seeks a Freelance Clinical Research Associate based in Italy to support an international Phase IV cardiology study. You will monitor investigator sites and manage close-out activities, with an expected workload of ~40% (0.4 FTE).

Local regulatory and ICH-GCP compliance are essential, and Italian operation as a freelancer is required. The role requires a Life Sciences degree and proven CRA experience, with fluency in Italian and professional English.

Qualifications

• Degree in Life Sciences or a related scientific field.
• Proven experience as a Clinical Research Associate.
• Strong knowledge of ICH-GCP guidelines.

Responsibilities

• Conduct monitoring visits and oversee study activities at investigator sites.
• Perform SDV and SDR, ensuring data accuracy and consistency with the EDC system.
• Ensure compliance with the study protocol, ICH-GCP guidelines, and Italian regulatory requirements.
• Follow up on outstanding queries, missing data, and discrepancies.
• Review and maintain ISF and TMF documentation for completeness and accuracy.
• Coordinate and perform study close-out activities across 6 investigator sites in Italy.

Skills

Monitoring visits

SDV/SDR

Regulatory compliance

Site close-out

Organization/detail

Education

Life Sciences degree

Job description

Clinact, a CRO, seeks a Freelance Clinical Research Associate based in Italy to support an international Phase IV cardiology study. You will monitor investigator sites and manage close-out activities, with an expected workload of ~40% (0.4 FTE).

Local regulatory and ICH-GCP compliance are essential, and Italian operation as a freelancer is required. The role requires a Life Sciences degree and proven CRA experience, with fluency in Italian and professional English.