Clinical Research Associate, South West England

Overview

In this role you support the execution of interventional studies as a Clinical Research Associate within IQVIA's sponsor-dedicated team. You will conduct on-site monitoring and ensure compliance with GCP/ICH while collaborating with sites to optimize recruitment and study conduct. You translate regulatory requirements into practical site management and maintain TMF/ISF documentation. The position offers growth within a global health-focused organization and opportunities to work with cross-functional teams on high-impact trials. You will contribute to delivering high-quality data and patient outcomes in a fast-paced environment.

Pay / Benefits

• Flexible working
• Well-being support
• Career development opportunities
• Mentorship opportunities
• Internal talent marketplace (Career Connections)

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with scope and GCP/ICH guidelines
• Collaborate with sites to drive recruitment to meet project needs
• Administer protocol training and maintain regular communication with sites
• Evaluate site practices for protocol conduct and regulatory compliance, escalating quality issues
• Track regulatory submissions, recruitment, CRF completion, data queries; support start-up as needed
• Maintain TMF/ISF documentation and ensure file readiness
• Create site management documentation, visit reports, and follow-up letters
• Collaborate with study team members for project execution

Key requirements

• At least 6 months independent on-site monitoring experience of interventional studies
• Experience across start-up, enrolment, maintenance, close-out
• Digital literacy with confidence using AI tools in a professional setting
• Degree in scientific discipline / health care or equivalent industry experience
• Knowledge of GCP and ICH guidelines
• Ability to build effective working relationships with coworkers and clients
• Full UK right to work (no visa sponsorship)

• strong communication and interpersonal skills
• ability to collaborate with cross-functional teams
• problem-solving and proactive issue escalation
• GCP and ICH regulatory knowledge
• on-site monitoring and trial management
• documentation and TMF/ISF upkeep

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