Senior Clinical Research Associate

Overview

In this role you will support the advancement of clinical development by conducting on-site monitoring and oversight of trial activities. You’ll collaborate with sites to ensure protocol adherence, data integrity, and regulatory compliance, contributing to efficient site performance. The position sits within IQVIA’s global network, leveraging data and training to drive better patient outcomes. You will work cross-functionally to manage recruitment, documentation, and quality issues, with a focus on growth and learning in a sponsor-dedicated environment.

Responsibilities

• Perform on-site monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP/ICH requirements
• Drive and track subject recruitment plans aligned with project needs
• Administer protocol training and maintain regular communication with sites
• Evaluate site practices for protocol conduct and regulatory adherence; escalate quality issues
• Monitor study progress: regulatory submissions, recruitment/enrollment, CRF completion/submission, data queries; may support start-up
• Ensure TMF/ISF documentation is accurate and up-to-date
• Create/maintain documentation of site management and monitoring findings; issue follow-up correspondence
• Collaborate with study team members to support project execution

Key requirements

• Minimum 18 months of independent on-site monitoring
• Experience managing multiple trials across diverse sites
• Strong knowledge of GCP and ICH guidelines
• Life science degree or equivalent industry experience
• Willingness to travel to sites

• Strong communication and collaboration
• Attention to detail and data integrity
• Problem-solving and issue escalation
• GCP governance
• ICH guidelines
• Regulatory submissions tracking

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