Experienced CRA - Single Sponsor Dedicated

Overview

In this role you will perform on-site monitoring to ensure study quality and regulatory compliance. You will collaborate with sites to manage recruitment, training, and documentation, while tracking study progress and data integrity. You’ll support trial start-up and generate reports to inform project decisions. The position offers exposure to global clinical development and a mission-driven culture focused on advancing patient outcomes.

Responsibilities

• Conduct site monitoring visits (selection, initiation, monitoring, close-out) per GCP/ICH and contract scope
• Drive and track subject recruitment to meet project needs
• Administer protocol training and maintain regular site communications
• Assess site practices for protocol adherence and regulatory compliance; escalate quality issues
• Track regulatory submissions, approvals, recruitment, CRF completion, data queries; support start-up as needed
• Maintain Trial Master File and Investigator's Site File in compliance with GCP/regulations
• Document site management activities and generate visit reports, follow-up letters, and other study documents
• Collaborate with study team to support project execution

Key requirements

• Experience of independent on-site monitoring (minimum 6 months)
• Managed multiple clinical trial protocols across diverse investigative sites
• Knowledge of GCP and ICH guidelines
• Life science degree or equivalent industry experience
• Flexibility to travel to sites

• Attention to detail
• Strong communication
• Problem-solving
• GCP
• ICH guidelines
• Site management documentation (TMF/ISF)

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