About the job
We are currently in search of a highly skilled Senior Clinical Research Associate with over 4 years of experience in monitoring intricate clinical trials within pharmaceutical, biotechnology, and CRO settings. The ideal candidate will demonstrate proven expertise in managing investigative sites, conducting site qualifications, initiation, routine monitoring (both on-site and remote), and closeout visits while ensuring adherence to ICH-GCP, regulatory requirements, and study protocols. You will be tasked with overseeing site performance, preserving data integrity through source data verification and CRF review, and maintaining timely documentation in eTMF, CTMS, and EDC systems. Additionally, you will support site start-up activities, provide training for investigators and site staff, and offer operational guidance to academic medical centers, particularly those with limited IND experience. The right candidate will possess strong capabilities in identifying operational risks, implementing effective mitigation strategies, and managing high volumes of clinical data to uphold patient safety, data quality, and study compliance. Reporting to the Lead CRA or Clinical Operations leadership, you will execute monitoring strategies and facilitate consistent oversight of assigned sites. We value collaboration and are looking for a team player who can work closely with investigative sites and cross-functional teams to enhance enrollment, address operational challenges, and ensure inspection readiness.

