Senior CRA

Clinical Monitoring:

• Lead on-site monitoring visits, ensuring excellence in execution and alignment with GCP/ICH, protocol, and SOPs.
• Dive into source data review/verification and drive swift, accurate query resolution to keep studies moving seamlessly.
• Continuously evaluate site performance, compliance, enrollment trends, and data quality to safeguard study success.

Operational Excellence:

• Craft, refine, and elevate SOPs, WIs, and operational tools that empower teams and strengthen quality.
• Identify operational gaps and champion process improvements that boost efficiency, consistency, and regulatory readiness.
• Contribute to study planning and risk management, playing an active role in inspection/audit readiness and overall operational excellence.

Study Management:

• Oversee IRB submissions and maintain a high-quality TMF, ensuring all essential documents are accurate, timely, and inspection-ready.
• Support key operational activities—including feasibility, regulatory submissions, site activation, IP logistics, and study tracking—to keep studies on course.
• Proactively spot issues, deviations, and risks, escalating and supporting effective CAPAs before they impact timelines.