Clinical Reseach Associate – UK – multi-sponsor

Overview

In this Clinical Research Associate role, you will monitor clinical sites to ensure regulatory and protocol compliance across multiple sponsors. You will work with site teams to protect data integrity and subject safety, handling source document reviews, IP management, and trial documentation. You’ll collaborate with cross-functional teams to keep timelines and study objectives on track, including remote and on-site oversight. This is a patient-facing, impact-driven position within a fast-paced, global environment that values practical problem-solving and continuous learning.

Responsibilities

• Perform site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) with focus on regulatory compliance
• Assess site performance and escalate issues to project team with action planning
• Maintain knowledge of ICH-GCP and applicable regulations and SOPs
• Verify informed consent processes and protect subject confidentiality
• Assess factors affecting subject safety and data integrity (protocol deviations, pharmacovigilance)
• Conduct Source Document Review and ensure accuracy/complete CRF data; drive query resolution
• Manage IP inventory, reconciliation, and adherence to labeling/import/export rules
• Review Investigator Site File and TMF alignment; ensure archiving of essential documents
• Document activities via letters, trip reports, logs and SOP-compliant records
• Support recruitment, retention, and awareness strategies; track observations and actions
• Understand project scope, budgets, and timelines; manage site-level communications to meet objectives
• Adapt to changing priorities; liaise with site personnel or Central Monitoring Associate
• Ensure site training/compliance with requirements; prepare for/involve in Investigator Meetings and sponsor meetings
• Support audit readiness and post-audit follow-up actions
• Maintain ongoing knowledge of GCP/regulations and complete required training

Key requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
• Strong computer skills and openness to new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to travel up to 75% regularly

• communication
• interpersonal skills
• problem-solving
• ICH-GCP knowledge
• regulatory compliance
• data entry and tracking systems

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