Freelance Clinical Research Associate (0.4FTE)

Hlx Life Sciences; Italia; On-site; EUR 33,000 - 47,000; Part time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Senior CRA experience

Oncology trials

Italy experience

ICH-GCP knowledge

Italian language

English language

Job description

Freelance Senior CRA - Italy | Oncology | 0.3-0.4 FTE

I’m currently supporting an international CRO looking for an experienced Freelance Senior CRA to provide support across an ongoing oncology study in Italy.

This role requires someone who can come into an active study, quickly understand the current status of their sites and work with a high level of autonomy.

The CRA will take ownership of assigned sites and be responsible for maintaining strong relationships with investigators and site teams, ensuring monitoring activities, documentation and follow-up actions are completed accurately and within required timelines.

Key responsibilities:

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

Requirements:

• Significant CRA/Senior CRA experience within Italy
• Strong and recent oncology clinical trial experience is essential
• Previous experience supporting ongoing Phase II/III studies would be highly desirable
• Strong understanding of ICH-GCP and Italian/EU clinical trial requirements
• Comfortable identifying and resolving site issues proactively
• Fluent Italian and strong professional English
• Available for approximately 0.3-0.4 FTE
• Available to start ASAP

This would be particularly well suited to an established freelance CRA who has capacity alongside an existing project and is looking for a longer-term, part-time oncology assignment.