Clinical Research Associate II

Overview

In this role you will support the IQVIA cFSP team by performing site monitoring across interventional studies and ensuring regulatory compliance. You will collaborate with study sites to manage recruitment, training, and ongoing study expectations, while safeguarding data quality and TMF accuracy. You will drive communication with sites and study teams to keep projects on track and compliant. This is a growth-focused opportunity to contribute to high-quality clinical research within a globally respected organization.

Pay / Benefits

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

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP/ICH guidelines
• Drive subject recruitment plans with sites to enhance predictability
• Administer protocol training and maintain regular communication with sites
• Assess site practices for protocol adherence and regulatory compliance; escalate quality issues
• Track regulatory submissions, approvals, recruitment, CRF completion, data queries; support start-up phase
• Ensure TMF filing and ISF maintenance according to GCP and local regs
• Document site management activities via visit reports, follow-up letters, and study docs
• Collaborate with study team members to support project execution

Key requirements

• At least 2 years of on-site monitoring experience in interventional studies
• Degree in scientific discipline or health care
• Strong knowledge of GCP and ICH guidelines
• Ability to build effective working relationships with coworkers and clients
• Full UK right to work (visa sponsorship not available)

• Strong communication
• Relationship-building
• Attention to detail
• On-site monitoring of interventional studies
• GCP/ICH compliance
• CRF completion and data query management

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