Unclassified - Basking Ridge, NJ
posted 3 months ago
The Clinical Study Specialist (CSS) provides essential technical and administrative support to the clinical study teams responsible for executing clinical trials. This role is pivotal in ensuring that studies are conducted efficiently and in compliance with regulatory standards. The CSS may be assigned to support the execution of one or more studies across a program, receiving assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will be involved in both internally sourced studies and those outsourced to Clinical Research Organizations (CROs). This position is hybrid, requiring the individual to work onsite three days a week, as 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 agendas, presentation materials, and minutes for clinical study team meetings. The CSS is responsible for collating data for assessments such as feasibility and site selection, reviewing site usability databases, and contributing to the review of study documents, including informed consent forms and case report forms, in accordance with company standard operating procedures. Additionally, the CSS compiles study manuals, maintains versioning of study reference materials, and collates materials for training and investigator meetings. The CSS also tracks site activation, enrollment, and monitoring visits against projected plans, escalating any issues or delays with site activation or deviations from the monitoring plan. They monitor and update investigator/site status for the trial, support clinical trial registry postings, and perform scheduled reconciliations of the study Trial Master File (TMF) under the guidance of the clinical study lead. Ensuring that scheduled reports are received, managing team SharePoint and/or shared drive sites, and maintaining communication with sites are also key responsibilities. The CSS may manage or contribute to the oversight of Third-Party Vendors (TPV) and track close-out activities, including study close-out documents and CRA close-out visits. Participation in Standard Operating Procedures (SOPs) revisions and departmental initiatives is expected, along with proactively recommending process improvement initiatives for the department.