Senior Clinical Research Associate/ Clinical Research Associate II

Overview

You will support and oversee clinical studies from a home-based role in the UK or Northern Ireland, ensuring studies are conducted to protocol, SOPs, and ICH-GCP standards. You will coordinate study setup and monitoring activities, including site identification, regulatory submissions, and initiation visits. You’ll thrive in a small-CRO environment, influencing outcomes through proactive planning and clear communication. This role offers work-life balance, meaningful impact on patient-focused oncology and rare-disease programs, and close collaboration with line management.

Responsibilities

• Monitor progress of clinical studies at investigative sites and ensure compliance with protocol, SOPs, ICH-GCP, and regulations
• Coordinate setup and monitoring activities for studies (identify investigators, assist with regulatory submissions, conduct pre-study and initiation visits)
• Ensure data integrity and timely reporting of study findings
• Identify risks and propose mitigation strategies to safeguard study quality
• Communicate effectively with cross-functional teams and site staff to keep projects on track
• Support line management with study-related decisions and issue resolution

Key requirements

• 4-year college degree or equivalent experience
• More than 1 year CRA experience in CRO or pharmaceutical industry (preferred)
• Oncology experience desirable but not essential
• 50-60% travel commitment (domestic; some international for senior roles)
• Fluent in English

• calm and thoughtful under pressure
• responsive and well-prepared with proactive thinking
• attention to detail
• ICH-GCP knowledge
• regulatory submissions support
• clinical site monitoring and data collection processes

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