Intuitive Surgical Careers
Clinical Research Associate - IDE
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 182403
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
The Clinical Research Associate will report to Manager, Clinical Affairs, and will play a key role to proactively support the conduct of pre-market clinical studies to ensure compliance with all the regulatory requirements. The ideal candidate will have thorough knowledge of Good Clinical Practices (GCP) and applicable regulations.
Qualifications• Support all clinical research activities essential to the successful management of pre market clinical studies under the direct supervision of clinical project manager or clinical affairs manager.• Maintain and track data of the clinical studies including investigator selection, analysis of potential patient recruitment, and overall study status/progress throughout the life of a study.• Manage site start-up/activation process, including: contributing to the preparation of study related documents (protocols, case report forms/eCRFs, informed consent forms, clinical trial agreements, budgets, clinical monitoring plan), organizing IRB/EC submissions and applicable regulatory documentation with follow through to ensure successful outcomes.• Amends clinical study documents as needed.• Collaborate with data management to ensure data cleaning process is performed and perform source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a paper case report form at sites to ensure regulatory and protocol compliance and overall accuracy.• Serve as main liaison to participating clinical trial sites with focus on data entry, query resolution, and overall site activity• Conduct clinical study on-site monitoring in accordance with the clinical monitoring plan.• Provide project administrative support including maintenance of study documentation (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.)• Track, process and manage site payments .• Assist Clinical Project Managers on study scoping activities, including but not limited to development of pre-study questionnaires, study design and surgeon/site selection• Perform site audits in preparation for site inspections• Maintain trial master file essential documents and clinical trial management system
• Possess basic knowledge of Good Clinical Practice and 21 CFR Part 11, 50, 54, 812 and international regulations• Bachelor’s degree in scientific field required• 5 years of experience in clinical trial operations and monitoring preferred• Clinical research/clinical trial management certification/education preferred• Must be clinically savvy and possess time management, organizational skills and problem-solving skills.• Excellent written and oral communication skills, problem-solving skills and interpersonal skills with high attention to detail and organization• Ability to work successfully in a team environment and ability to prioritize and manage multiple tasks as necessary.• Proficiency in Microsoft Office, including Word, PowerPoint, Visio and Excel• Experience working with electronic data capture systems• Experience in medical device industry required• Must be able to travel up to 30%Ability to multi-task and work in a dynamic environment with simultaneous projects/tasks
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.