Intuitive · 23 hours ago
Senior Clinical Research Associate
Sunnyvale, CA
Full-time
Onsite
Senior Level, Lead/Staff
$129K/yr - $185K/yr
8+ years expIntuitive is a pioneer in robotic-assisted surgery, committed to enhancing minimally invasive care through innovative technology. The Senior Clinical Research Associate will support pre-market clinical studies of investigational drugs in oncology, ensuring compliance with regulatory standards while collaborating with key stakeholders. This role involves coordinating clinical study activities, managing data, and conducting site visits to ensure study success.
Health CareManufacturingMedical Device
Responsibilities
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
Qualification
Required
Previous experience implementing oncology 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 multiple priorities
Excellent communication, presentation and relational skills with high attention to detail and organization
Ability to learn quickly, adjust to shifting requirements, and self-educate on different as applicable to clinical projects ('Self-starter attitude')
Exhibits solid work ethic to help meet tight timelines and/or multiple priorities when necessary with a problem-solving mindset
Proficiency in Microsoft Office Suite, PDF applications
Experience working with electronic data capture (EDC) systems required
Experience in clinical trial management systems
Experience in oncology required
Previous experience implementing, helping and managing drug trials
Significant knowledge of clinical and/or outcomes research study
Possess advanced knowledge of Clinical investigation of Investigational drugs for human subjects - Good Clinical Practice and other applicable regulations
Knowledge of clinical research and monitoring requirements
Excellent ability to interact with physicians and other professionals inside and outside the company
Typically requires a minimum of 8 years of related experience with a BA/BS university degree; or a minimum 6 years' experience and a Nursing degree, a Master's degree, or an MD or PhD with a minimum 5 years' of clinical research experience
Preferred
Knowledge of statistics, statistical methods, and design of experiment is preferred
Accustomed to working in a hospital environment, experience working with nurses and surgeons preferred
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Craig Child
Sr. Vice President, Human Resources
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Recent News
2025-12-11
2025-11-14
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