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Senior Clinical Research Associate at eGenesis | Cambridge, MA

eGenesisCambridge, MA
On-site Full-time

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Experience Level

Experience

Qualifications

Essential qualifications for the role include:4+ years of experience in clinical trial monitoring within pharmaceutical, biotechnology, or CRO environments. Proven experience in managing investigative sites and conducting site qualification, initiation, routine monitoring, and closeout visits. Deep understanding of ICH-GCP and regulatory requirements. Strong skills in data integrity maintenance through source data verification and CRF review. Experience with eTMF, CTMS, and EDC systems. Ability to provide training for site staff and operational guidance. Excellent risk identification and mitigation strategy implementation skills. Strong organizational and communication skills to collaborate effectively with cross-functional teams.

About the job

Join eGenesis as a Senior Clinical Research Associate
At eGenesis, we are at the forefront of innovation in biotechnology, developing human-compatible engineered organs to combat the critical global organ shortage. Our cutting-edge genome engineering platform allows for extensive gene modifications, effectively removing biological barriers and introducing protective human transgenes. Our leading program, EGEN-2784, involves a genetically engineered porcine kidney currently under a multi-patient Expanded Access study at Massachusetts General Hospital (MGH). We are proudly headquartered in Cambridge, MA, and are dedicated to making a significant impact on healthcare.

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.

About eGenesis

eGenesis is a pioneering clinical-stage biotechnology firm dedicated to developing human-compatible engineered organs, significantly addressing the global organ shortage crisis. Our innovative genome engineering technologies set us apart as we work towards transformative solutions in healthcare.

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