Clinical Research Associate

Overview

In this role you will support Oncology studies across Ireland and Northern Ireland, performing site monitoring and ensuring GCP compliance. You will maintain strong site relationships, drive subject recruitment alignment with project needs, and manage study documentation and TMF/ISF accuracy. You will work with cross‑functional teams to enable smooth study execution and issue resolution. This is a mission‑driven opportunity to contribute to impactful oncology research and patient outcomes.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP
• Collaborate with sites to drive subject recruitment and improve predictability
• Provide protocol and study training to sites and maintain regular communication
• Assess site practices for protocol conduct and regulatory adherence; escalate quality issues
• Track regulatory submissions, approvals, recruitment, CRF completion, data queries; support start-up if needed
• Ensure TMF/ISF documentation is complete and maintained in line with GCP and local regs
• Document site management activities and findings; generate reports and follow-up letters
• Coordinate with study team for project execution and issue resolution

Key requirements

• Experience of independent on-site monitoring in Oncology for unblinded studies
• Strong knowledge of GCP and ICH guidelines
• Life science degree or equivalent industry experience
• Flexibility to travel to sites as required
• Please note – this role is not eligible for visa sponsorship

• clear communication
• collaboration
• problem-solving
• GCP/ICH knowledge
• site monitoring processes
• regulatory submissions and TMF/ISF management

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