Regeneron Pharmaceuticals - Basking Ridge, NJ
posted 3 months ago
The Clinical Study Specialist (CSS) at Regeneron Pharmaceuticals Inc. plays a crucial role in providing both technical and administrative support to the clinical study teams responsible for executing clinical trials. This position is essential for ensuring that studies are conducted efficiently and in compliance with regulatory standards. The CSS may be assigned to support one or more studies across a program, receiving assignments from the Clinical Study Lead or Clinical Study Associate Manager. The role involves supporting both internally sourced studies and those outsourced to Clinical Research Organizations (CROs). As a hybrid position, the CSS is required to work onsite three days a week, with the expectation that fully remote work is not an option. A typical day for a CSS may include organizing and delivering analyzable reports and metrics to the clinical study lead, scheduling and coordinating meetings, and preparing necessary materials such as agendas and minutes for clinical study team meetings. The CSS is also responsible for collating data for assessments like feasibility and site selection, contributing to the review of study documents, and compiling study manuals while maintaining version control of study reference materials. In addition to these tasks, the CSS tracks site activation, enrollment, and monitoring visits, escalating any issues or delays as necessary. They monitor and update the status of investigators and sites for the trial, support clinical trial registry postings, and perform scheduled reconciliations of the Trial Master File (TMF) under the guidance of the clinical study lead. The CSS also manages team SharePoint and shared drive sites, communicates with sites as directed, and may oversee Third-Party Vendors (TPV). The role requires proactive recommendations for process improvements and participation in revisions of Standard Operating Procedures (SOPs) or departmental initiatives. This position is ideal for individuals with a strong attention to detail, excellent communication and interpersonal skills, and the ability to form relationships both internally and externally. The CSS must be resourceful, demonstrate problem-solving skills, and proactively assess information to understand its impact on clinical trials.