Lead Clinical Research Associate

The Lead Clinical Research Associate is responsible for leading site monitoring activities and providing oversight to CRAs for assigned clinical trials at eGenesis, a clinical-stage biotechnology company developing human-compatible engineered organs. The role involves providing operational leadership, monitoring strategy alignment, issue escalation, and mitigation of site risks and operational challenges. The ideal candidate will have a Bachelor’s degree in life sciences, nursing, or related field, and 5+ years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry.

Requirements

• Provide operational leadership and guidance to internal CRAs and oversight of external (CRO/vendor) CRAs
• Author the Clinical Monitoring Plan (CMP) and develop study-specific monitoring tools, trackers, and guidance
• Review monitoring outputs and conduct oversight monitoring activities
• Develop and deliver training materials and guidance for CRAs and study site personnel
• Track study startup activities, activation timelines, and site/study performance metrics
• Monitor site enrollment performance and implement mitigation strategies
• Investigate protocol deviations, monitoring findings, and site compliance issues
• Ensure compliance with ICH-GCP, federal regulations, monitoring plans, and internal SOPs

Benefits

• Base pay range $131,200-$196,800