Senior Oncology CRA - Italy | Part-Time 0.3–0.4 FTE

Hlx Life Sciences; Italia; Presencial; EUR 33 000 - 47 000; Tempo parcial

Resumo da oferta

Hlx Life Sciences is seeking a Freelance Senior CRA to support an ongoing oncology study in Italy, at 0.3-0.4 FTE. You will come into an active study with autonomy, manage assigned sites, and drive monitoring activities to ensure data quality and regulatory compliance.

You will monitor on-site and remotely, build strong investigator relationships, and maintain timely documentation. Fluency in Italian and strong English are required, with availability ASAP.

Qualificações

• Significant CRA/Senior CRA experience within Italy.
• Strong oncology clinical trial experience essential.
• Experience supporting ongoing Phase II/III studies desirable.
• Strong understanding of ICH-GCP and Italian/EU trial requirements.
• Fluent Italian and professional English.

Responsabilidades

• Independently manage assigned investigational sites in Italy.
• Conduct on-site and remote monitoring activities in line with monitoring plan.
• Build and maintain relationships with investigators, study coordinators and site teams.
• Complete monitoring visit reports accurately and within timelines.
• Proactively manage outstanding site actions and follow-up to resolution.
• Perform source data review/verification and ensure data quality and protocol compliance.
• Review essential documentation and support ISF/TMF completeness.
• Identify potential site risks and escalation issues appropriately.
• Support resolution of data queries, protocol deviations and monitoring findings.
• Ensure sites remain compliant with protocol, ICH-GCP and Italian/EU requirements.
• Maintain regular communication with the study team regarding progress and risks.
• Support sites in maintaining inspection readiness.

Conhecimentos

Senior CRA experience

Oncology trials

Italy experience

ICH-GCP knowledge

Italian language

English language

Descrição da oferta de emprego

Hlx Life Sciences is seeking a Freelance Senior CRA to support an ongoing oncology study in Italy, at 0.3-0.4 FTE. You will come into an active study with autonomy, manage assigned sites, and drive monitoring activities to ensure data quality and regulatory compliance.

You will monitor on-site and remotely, build strong investigator relationships, and maintain timely documentation. Fluency in Italian and strong English are required, with availability ASAP.