Clinical Monitoring Associate – Site & Study Operations

IQVIA LLC; England; On-site; GBP 32,000 - 52,000; Full time

Job summary

IQVIA LLC in the United Kingdom is seeking a Clinical Research Associate to perform site monitoring visits in line with GCP/ICH and contracted scope. You will collaborate with sites to drive recruitment plans and ensure protocol training and regular communication.

The role focuses on evaluating site practices, managing regulatory submissions, and maintaining TMF/ISF documentation, with close collaboration across the study team to support project execution.

Qualifications

• GCP/ICH knowledge (implied by role)
• Regulatory compliance awareness (implied)

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with scope and GCP/ICH guidelines.
• Work with sites to adapt, drive, and track subject recruitment plans to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular communication to manage expectations and issues.
• Evaluate site practices for protocol conduct and adherence to regulations; escalate quality issues as appropriate.
• Manage progress of assigned studies by tracking regulatory submissions, approvals, recruitment/enrollment, CRF completion and data query resolution; may support start-up phase.
• Ensure copies/originals of site documents are filed in the Trial Master File and ISF maintained per GCP and local requirements.
• Create and maintain documentation regarding site management, monitoring visit findings and action plans; submit visit reports and follow-up letters.
• Collaborate with study team members for project execution support.

Job description

IQVIA LLC in the United Kingdom is seeking a Clinical Research Associate to perform site monitoring visits in line with GCP/ICH and contracted scope. You will collaborate with sites to drive recruitment plans and ensure protocol training and regular communication.

The role focuses on evaluating site practices, managing regulatory submissions, and maintaining TMF/ISF documentation, with close collaboration across the study team to support project execution.