Clinical Research Associate- North West England

About this role

Responsibilities

• Build and sustain strong relationships with investigative sites across all trial phases.
• Perform site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws/regulations, protocol, site monitoring plans, and related documents.
• Develop deep understanding of study protocols and procedures.
• Coordinate cross-functional tasks to achieve Site Ready status.
• Participate in site selection and validation; provide informed input to decisions.
• Conduct remote and on-site monitoring to ensure:
• Data integrity (complete, accurate, unbiased).
• Protection of subjects’ rights, safety, and well-being.
• Execute validation, initiation, monitoring, and close-out visits; document clear, comprehensive visit and non-visit reports in a timely manner.
• Collect, review, and monitor regulatory documentation for start-up, maintenance, and close-out.
• Communicate proactively with investigators and site staff on protocol conduct, recruitment/retention, deviations, regulatory findings, audits/inspections, and site performance.
• Identify, assess, and resolve site performance, quality, or compliance issues; escalate appropriately per the CRA escalation pathway in collaboration with CRA Manager, CRM, TA Head, and CRD.
• Partner with internal teams (country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ) and external stakeholders (vendors, IRB/IEC, regulatory authorities).
• Maintain accurate, timely documentation in CTMS, eTMF, and other systems.
• Act as a process SME: share best practices, drive continuous improvement, and deliver training.
• Support and/or lead audit/inspection activities.
• Contribute to country strategy by identifying and onboarding potential new sites; build site capabilities.
• Mentor and buddy junior CRAs; conduct co-monitoring and quality control visits where appropriate.
• Travel requirements
• Ability to travel domestically and internationally approximately 65–75% of working time (about 2–3 days per week).
• Valid driver’s license preferred; required in certain countries.
• Qualifications, skills, and experience
• Core competencies
• Fluent in English, with strong written and verbal communication skills and the ability to present technical information effectively.
• Robust knowledge of clinical research, trial phases, ICH/GCP, and local clinical research regulations and guidelines; ability to work within global, country, and regional frameworks.
• Demonstrated mentoring and leadership capability.
• Hands-on knowledge of Good Documentation Practices.
• Proven site management expertise, including independent oversight of site performance and patient recruitment.
• High-level monitoring skills with sound, independent professional judgment.
• Strong IT proficiency (MS Office and clinical applications across computer, tablet, and mobile); adaptable to new tools.
• Ability to interpret data/metrics and take appropriate action, including in virtual settings.
• Experience conducting site motivation visits to boost enrollment.
• Solution-oriented approach to complex issues; capable of root cause analysis and implementing preventive/corrective actions.
• Ability to mentor junior CRAs and perform co-monitoring visits.
• Behavioral competencies
• Excellent time management, organization, interpersonal skills, conflict management, and problem solving.
• High independence across multiple protocols, sites, and therapy areas.
• Strong sense of accountability and urgency; able to prioritize and multitask in changing environments.
• Effective in a matrixed, multicultural setting; fosters culturally sensitive relationships.
• Customer-focused mindset with high standards of quality and compliance.
• Positive, growth-oriented, self-driven, and professional demeanor aligned with company values.
• Education and experience
• Bachelor’s degree (or higher) with extensive direct site management (monitoring) in bio/pharma/CRO.