CRA 2 - Single Sponsor Dedicated

Overview

In this role you will monitor and manage clinical sites to ensure studies are conducted in line with the protocol, GCP, ICH guidelines, and sponsor requirements. You will work with sites to drive recruitment, administer protocol training, and maintain high-quality study documentation. You’ll track regulatory submissions, enrollments, CRF completion, and queries, while collaborating with the study team to support project execution. This position offers exposure to site management across multiple UK sites and contributes to delivering reliable trial data and patient outcomes.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and GCP
• Support subject recruitment planning to improve predictability
• Administer protocol training and maintain regular site communication
• Assess site practices for protocol adherence and regulatory compliance; escalate quality issues
• Track regulatory submissions, approvals, recruitment, CRF completion, and data queries; may support start-up
• Ensure TMF/ISF documentation is accurate and up-to-date
• Document monitoring findings and action plans via visit reports and follow-up letters
• Collaborate with study team for project execution support
• May support development of site recruitment plans on a per-site basis
• May oversee site financial management and invoices per the clinical trial agreement

Key requirements

• Bachelor's Degree in scientific discipline or health care preferred
• 1+ year of on-site monitoring experience
• Equivalent combination of education, training and experience may be accepted
• Knowledge of GCP and ICH guidelines
• Therapeutic and protocol knowledge provided in training
• Proficiency with Microsoft Word, Excel and PowerPoint; familiarity with laptops, iPhone/iPad where applicable
• Written and verbal English communication skills
• Strong organizational and problem-solving abilities
• Time and financial management skills
• Ability to build effective working relationships with coworkers, managers, and clients

• excellent communication
• strong organizational skills
• problem-solving capability
• GCP and ICH knowledge
• MS Office (Word, Excel, PowerPoint)
• clinical trial documentation practices (TMF/ISF)

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