Sr. CRA

About the role

We are seeking an experienced professional who can immediately provide hands-on monitoring and data-readiness support for an active, sponsor-led Phase 1 gene therapy study approaching an interim data freeze. The candidate will partner with CTM/COL to ensure site-related monitoring activities through close-out activities are conducted as per GCP and regulatory requirements. Join our team in beautiful San Diego, CA, where you can advance your career in a dynamic and innovative environment while enjoying the benefits of living in a vibrant coastal city.

Responsibilities

• Completing monitor trip report reviews
• Site audit reviews
• On-site assessments for quality, GCP, and regulatory compliance
• Data cleaning and monitoring gene therapy clinical studies for adherence to protocol, ICH/GCP, SOPs, and follows Clinical Monitoring Plan; i.e., on-site and remote visits, create trip reports