Sr. Clinical Research Associate

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 more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. The Future Forward organization is Intuitive’s advanced concepts group. We explore emerging technologies, prototype next-generation solutions, and build software experiences that shape the future of robotic-assisted surgery. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare , you’ll find your purpose here. Primary Function of the Position The Senior Clinical Research Associate will play a vital role in supporting pre-market clinical studies of investigational drugs for the Fluorescence Imaging group, ensuring full compliance with regulatory requirements. The ideal candidate will have in-depth knowledge of clinical research in drug trials, including Good Clinical Practice (GCP) and relevant US regulations for human subjects. As a member of the Clinical Fluorescence Imaging team, this individual will collaborate with key stakeholders and contribute to the successful execution of pre-market clinical studies, working independently with minimal supervision. The role will involve close coordination with Senior Clinical Project Managers, the Head of the Fluorescence Imaging Clinical Team, and other team members. The Sr CRA will also travel frequently to Investigational Sites to conduct co-monitoring along with the assigned Field CRA(s)/Monitor(s) assigned to specific investigational sites by the CRO. Essential Job Duties Contribute to all clinical research activities to ensure the successful start-up and management of clinical studies through FDA approval. Maintain and track clinical study data monitored and help in Investigator, Sub-Investigators qualification and selection, training, scrutiny of potential patient recruitment, and overall study status/progress throughout the life of a study. Co-Management of site start-up/activation process, including heavy contribution to the preparation of study-related documents and complete checklists, able to help with clinical trial agreements and budget negotiation, finalization of clinical monitoring plan, training materials, etc. Assist with eCRFs/EDC system, CTMS, eTMF and imaging Core Labs. Assist with review of IRB submissions, consents and applicable regulatory documentation with follow-through to ensure successful outcomes. Assist with amendments clinical study documents (ICF, CRFs, protocols, Monitoring Plan, study tools, etc.) as needed and assist clinical sites with institutional review board submission if necessary. Experienced with performing on-site and/or remote site qualification visits, site initiation visits, interim co-monitoring visits, and site close-out visits with or without the CRO. Conduct clinical study co-monitoring to ensure regulatory and protocol compliance and overall data accuracy in accordance with the study clinical monitoring plan. Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites to ensure regulatory and protocol compliance and overall accuracy. Assist and support participating clinical trial sites, to ensure timely data entry, data integrity, query resolution, investigational drug accountability, and study conduct oversight at the participating clinical sites. Partner with data management (CRO) to help the data cleaning process. Assist with the development and management of study electronic clinical trial master file (eTMF) and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.) Assist the Sr Clinical Project Manager on study scoping activities, including, but not limited to, the development of pre-study questionnaires, study design, and surgeon/site selection. Assist Investigational sites with site audits preparation in anticipation of site inspections as well as assist during actual audits. Assist with internal and external audits preparation as well as during actual audits. Assist with SIV preparation and presentations. Assist with Investigators meetings preparation and presentations, including logistics and planning. Qualifications Required Skills and Experience Previous experience implementing pharmaceutical trials. Significant knowledge of clinical and/or outcomes research study design. Experience with surgical trials is preferred. Possess advanced knowledge of Clinical investigation of investigational drugs for human subjects. Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements. Clinical research/clinical trial management certification/education preferred. Excellent ability to interact with physicians and other professionals inside and outside the company. Excellent communication skills. Experience with protocol and ICF development, and related amendments. Experience negotiating clinical research contracts and budgets. Must be able to work effectively cross-functionally. Must be able to travel up to 40%. Must be able to manage mu