Senior Clinical Research Associate

Regional CRA – Oncology | Italy | Remote | FSP

We are supporting an advanced global FSP partnership with a US-based oncology biotech seeking an experienced Regional CRA to join a high-performing clinical operations team.

This is a remote-based opportunity in Italy supporting Phase I–III oncology studies across both liquid and solid tumours. The role offers exposure to innovative early-phase research within a collaborative biotech environment.

Key Responsibilities:

• Full site management from start-up through close-out

• Routine monitoring visits across oncology studies

• Support feasibility and site selection activities

• Partner closely with investigators, CROs, and study coordinators

• Ensure compliance with ICH-GCP, SOPs, and regulatory requirements

• Support patient recruitment and study delivery timelines

• Mentor junior CRAs where required

Requirements:

• Minimum 5 years CRA monitoring experience

• Strong Phase I oncology experience

• Background in liquid and solid tumour studies

• Experience with in pharma/biotech clinical trials

• Strong knowledge of GCP, EDC, CTMS, and clinical operations

• Ability to manage multiple protocols and sites effectively

Additional Details:

• Remote-based in Italy

• 70–80% travel required

• 8–10 sites across 4–5 protocols maximum