The Senior Clinical Research Associate (Sr. CRA) plays a critical role in the management, monitoring, and execution of clinical trials and is responsible for ensuring trials are conducted in compliance with regulatory requirements, company SOPs, and industry best practices. The Sr. CRA will work closely with cross-functional teams to ensure the successful execution of clinical studies.
Responsible for overseeing all aspects of clinical study management for a gene therapy product. Able to successfully manage one or more complex studies with minimal supervision. Responsibilities include study planning and execution, timelines, budget, clinical site and vendor management. Comfortable working independently, managing interactions with experienced clinical monitors and cross-functional internal/external project stakeholders.
This position is responsible for collaborating with both internal and external stakeholders to deliver the execution of our Biostatistics strategy. The individual in this position will have the unique opportunity to participate in the rapid growth of a biotech startup.