Clinical Trial Assistant

What you'd do

• 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

What they want

• Excellent communication, organization and interpersonal skills with strong attention to detail
• Strong ability to organize, prioritize and manage multiple priorities
• Prior experience in medical device clinical trials, regulatory support, clinical project coordination
• Proficient in MS Office suite, Adobe, video and web conferencing solutions
• Clinically savvy & good knowledge of basic medical terminology preferred
• Possess working knowledge of Good Clinical Practice as detailed in 21CFR and ISO 14155, and regulation such as 21 CFR Part 812
• Minimum of 2-4 years of related experience in clinical research with high school diploma or secondary education or equivalent
• Minimum Bachelor’s degree is a plus
• Research/clinical trial management certification/ education is a plus
• Able to travel up to 10%

About Intuitive Surgical · Public Relations

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and…