CRA2 - Multi-Sponsor Department

Overview

In this role you support multi-site clinical research by conducting site monitoring in line with GCP/ICH. You work closely with investigators to drive subject recruitment, deliver protocol training, and maintain compliant documentation. You assess site performance and quality, escalating issues when needed, and coordinate study progress across teams. The opportunity combines field travel with a focus on data integrity and patient outcomes within a global, purpose-driven organization.

Responsibilities

• Conduct site monitoring visits (selection, initiation, monitoring, close-out) per scope and regulations (GCP/ICH)
• Support recruitment planning with sites to improve predictability
• Administer protocol training and maintain ongoing site communications
• Evaluate site practices for protocol conduct and regulatory adherence; escalate quality issues
• Track regulatory submissions, approvals, enrollment, CRF completion, data queries, and overall study progress
• Maintain Trial Master File (TMF) and Investigators Site File (ISF) in line with GCP/regulations
• Create and maintain site management documentation, visit reports, and follow-up letters
• Collaborate with study team members to support project execution

Key requirements

• Experience of independent on-site monitoring
• Managed multiple clinical trial protocols across diverse sites
• In-depth knowledge of GCP and ICH guidelines
• Life science degree or equivalent industry experience
• Flexibility to travel to sites
• communication skills
• collaboration
• flexibility
• GCP
• ICH guidelines
• CRF completion and data query management

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