Clinical Research Associate – North West England

Overview

As a Clinical Research Associate, you will lead site performance and compliance for assigned protocols, ensuring ICH/GCP adherence and regulatory alignment. You’ll act as the primary site contact across study phases while expanding our clinical network and sharing monitoring expertise across teams. The role emphasizes data integrity, patient safety, and cross-functional collaboration to drive successful trials. You will work in a global context with travel to domestic and international sites, contributing to country strategy and site onboarding.

Pay / Benefits

• Competitive compensation and benefits

Responsibilities

• Build and sustain relationships with investigative sites across trial phases
• Monitor activities ensuring ICH-GCP, Sponsor SOPs, and local regulations compliance
• Develop deep understanding of study protocols and procedures
• Coordinate cross-functional tasks to achieve Site Ready status
• Participate in site selection and validation with input to decisions
• Conduct remote and on-site monitoring for data integrity and patient safety
• Execute validation, initiation, monitoring, and close-out visits with clear reports
• Collect, review, and monitor regulatory documents for start-up and close-out
• Communicate proactively on protocol conduct, recruitment, deviations, regulatory findings, audits, and site performance
• Identify and resolve site performance, quality, or compliance issues; escalate per CRA pathway
• Partner with internal teams and external stakeholders (vendors, IRB/IEC, regulatory authorities)
• Maintain accurate documentation in CTMS, eTMF, and other systems
• Act as process SME; drive best practices and training
• Support and/or lead audit/inspection activities
• Contribute to country strategy by identifying and onboarding new sites
• Mentor and buddy junior CRAs; conduct co-monitoring and QC visits

Key requirements

• Fluent in English with strong written and verbal communication
• Robust knowledge of clinical research, ICH/GCP, and local regulations
• Mentoring and leadership capability
• Hands-on knowledge of Good Documentation Practices
• Proven site management expertise and independent oversight of site performance
• Strong monitoring skills and independent judgment
• High IT proficiency with MS Office and clinical applications
• Ability to interpret data/metrics and act, including in virtual settings
• Experience conducting site motivation visits to boost enrollment
• Problem-solving and root-cause analysis with preventive/corrective actions
• Ability to mentor junior CRAs and perform co-monitoring visits

• Excellent time management
• Organizational skills
• Interpersonal and conflict management
• ICH/GCP
• GCDMP
• Good Documentation Practices

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