Senior Clinical Research Associate, Field Monitor

Role: Senior Clinical Research Associate responsible for overseeing clinical trial conduct to ensure high-quality, compliant research in immunotherapy and cell therapy programs, including FDA Breakthrough Therapy designations. Core responsibilities include executing site visits (site selection, initiation, monitoring, close-out), implementing risk-based monitoring strategies aligned with ICH E6(R3), and providing expert protocol interpretation to sites. The role involves data verification, managing essential documentation in eTMF, supporting patient recruitment, and ensuring site adherence to Good Clinical Practice (GCP) and regulatory standards. Qualifications: Bachelor's degree in a health-related discipline or RN with 5+ years of on-site monitoring; minimum of 6 years clinical trial experience in biotech, pharma, or CRO environments; at least 4 years of independent monitoring. Skills include proficiency in EDC, eTMF, CTMS, strong communication, organizational, and collaborative abilities, and knowledge of drug development processes and regulatory guidelines. High-Value: Focus on immuno-oncology, biologics, early to late-phase (Ph1-3), and experience supporting multicenter trials with a high travel requirement (up to 75%). The position offers remote work flexibility, with significant travel, and reports to senior clinical management.