Clinical Trial Assistant

Job Description Primary Function of Position: The Clinical Trial Assistant will play a key role to provide operational support to coordinate the conduct and management of clinical studies to ensure compliance with Intuitive standard operating procedures, Good Clinical Practices (GCP), good documentation practices, and applicable regulations. The ideal candidate will have good understanding of clinical trials regulatory requirements. This position is based at the Intuitive Surgical Seattle office in Seattle, Washington. Roles & Responsibilities: Coordinate and manage the ordering, shipping, labeling and tracking of study supplies (including investigational products) with limited supervision Establish, organize and maintain electronic study files and trial master files, with CRO as applicable, to ensure regulatory and protocol compliance including maintenance of study essential documentation (e.g., correspondence, CRFs, study approval documents, curriculum vita, etc…), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.) Contribute to operational excellence and continuous improvement Maintain, track and facilitate routing for approval and signature of clinical study documents including protocols, case report forms, Informed consents, Clinical trial agreements, non-disclosure agreements, etc Create purchase requests and process invoices Support clinical study manager with study budget tracking and payments of clinical sites and vendors Prepare and ship site binders and patient binders as necessary Collaborate with Clinical Study Managers (CSM) to develop clinical study informational materials such as newsletters, recruitment materials, etc Collaborate with Clinical Research Associates (CRA), Clinical Study Managers (CSM) and Clinical Managers to support study execution Provide administrative support to coordinate, schedule and plan study and investigators meetings, teleconferences, distributing agendas and meeting minutes #J-18808-Ljbffr