Senior CRA - Freelance, Global On‑Site Monitoring

Psi CRO; Lombardia; Presencial; EUR 77.000 - 125.000; Jornada completa

Descripción de la vacante

Psi CRO is seeking an experienced Freelance Senior Clinical Research Associate to join our monitoring team in Italy. You will conduct site visits, ensure ICH-GCP compliance, manage site relationships, monitor timelines, and support TMF and regulatory submissions. Independent, highly organized professionals with 3+ years of on-site monitoring in Italy and English proficiency are invited to apply.

Travel within Italy is required; driver’s license preferred. Oncology experience is a plus.

Formación

• Requires degree in Life Sciences or equivalent.
• Minimum 3 years of independent on-site monitoring experience in Italy across multiple trials.
• Experience conducting monitoring visits in Phase I–III trials.
• Good command of English (written and spoken).
• Knowledge of ICH-GCP guidelines and trial regulations.
• Willingness to travel; valid driver’s license.

Responsabilidades

• Preparing, conducting, and reporting on monitoring visits (site selection, initiation, routine monitoring, close-out).
• Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements.
• Maintain relationships with investigators and site staff.
• Monitor patient recruitment, study timelines, and site performance.
• Perform source data verification and data queries; manage site-level risks.
• Oversee investigational product accountability, trial supplies, and TMF reconciliation.
• Deliver site staff training and support regulatory submissions and audits.
• Provide guidance to less experienced CRAs; work in an international team.

Conocimientos

Independent on-site monitoring

English proficiency

Travel willingness

Organizational skills

Communication

Problem solving

Team collaboration

Driver's license

Educación

Life Sciences degree

Herramientas

MS Office

Descripción del empleo

Psi CRO is seeking an experienced Freelance Senior Clinical Research Associate to join our monitoring team in Italy. You will conduct site visits, ensure ICH-GCP compliance, manage site relationships, monitor timelines, and support TMF and regulatory submissions. Independent, highly organized professionals with 3+ years of on-site monitoring in Italy and English proficiency are invited to apply.

Travel within Italy is required; driver’s license preferred. Oncology experience is a plus.