Senior Clinical Research Associate

The Senior Clinical Research Associate (Sr. CRA) plays a critical role in the management, monitoring, and execution of clinical trials. This position will lead and manage all aspects of assigned clinical trials, from site selection and initiation to study close-out. The role involves developing and implementing study plans, timelines, and budgets in collaboration with the Clinical Project Manager as well as coordinating with cross-functional teams to ensure that study objectives are met. The Sr. CRA will conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols, GCP, and applicable regulations, including FDA regulations, ISO standards, and other relevant regional regulations and guidelines. This position ensures proper documentation and maintenance of the Trial Master File (TMF) in accordance with regulatory requirements. They will also oversee data collection and ensure data integrity and quality across clinical sites.