Senior Clinical Research Associate, Sponsor Aligned, Oncology

IQVIA seeks a Senior Clinical Research Associate to oversee oncology trial sites, ensuring protocol compliance and regulatory adherence. The role involves site monitoring, recruitment support, training, and quality assurance for Phase 1 cancer studies across multiple locations.

Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits per GCP and ICH standards
• Collaborate with sites on recruitment planning and tracking to meet enrollment targets
• Deliver protocol training and maintain regular site communication to manage expectations
• Assess site compliance with study protocols and regulatory requirements, escalating issues
• Oversee regulatory submissions, data queries, CRF completion, and documentation in TMF and ISF

Requirements

• Bachelor's degree required; scientific or healthcare discipline preferred
• 3+ years on-site oncology monitoring experience strongly preferred, or 1.5+ years considered
• Phase 1 oncology trial experience required
• Proficiency in GCP and ICH guidelines
• Strong protocol knowledge and therapeutic expertise in Phase 1 oncology
• Proficient with Microsoft Office and mobile devices
• Excellent communication, organizational, and problem-solving skills

Compensation: $71,900-$189,000 base