Senior Clinical Research Associate, Oncology (Sponsor Aligned)

About the role

iQVIA is hiring a Senior Clinical Research Associate, sponsor aligned, for oncology. You will monitor and manage clinical trial sites to ensure compliance with study protocols, regulations and sponsor requirements, working on Phase 1 oncology trials. The potential base pay range, when annualized, is $71,900 to $189,000.

Key responsibilities

• Conduct site selection, initiation, monitoring and close-out visits in line with GCP and ICH guidelines.
• Collaborate with sites to develop and track recruitment plans.
• Provide protocol and study training to sites and keep regular communication to manage expectations and resolve issues.
• Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed.
• Oversee regulatory submissions, recruitment, enrollment, CRF completion and data query resolution, and support start-up phases.
• Ensure site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF).
• Generate visit reports, follow-up letters and other required documentation.
• Mentor clinical staff through co-monitoring and training visits, and work closely with the study team.

Required profile

• BS degree required; a degree in a scientific discipline or healthcare is preferred.
• Phase 1 oncology experience is required.
• 3+ years of on-site oncology monitoring experience strongly preferred; 1.5+ years may be considered.

Required skills

• Proficiency in GCP and ICH guidelines.
• Strong therapeutic and protocol knowledge in Phase 1 oncology trials.
• Excellent computer skills, including Microsoft Office and mobile devices.
• Effective communication, organization, problem-solving and time management, and ability to build working relationships.