Intuitive · 22 hours ago
Sr. Clinical Research Associate
Sunnyvale, CA
Full-time
Onsite
Senior Level
$129K/yr - $185K/yr
6+ years expIntuitive is a pioneer and market leader in robotic-assisted surgery, committed to enhancing minimally invasive care. The Senior Clinical Research Associate will oversee pre-market and post-market clinical studies, ensuring compliance with regulatory requirements and collaborating with various stakeholders to execute studies effectively.
Health CareManufacturingMedical Device
Responsibilities
Contribute to all clinical research activities to ensure the successful management of clinical studies
Maintain and track clinical study data and help in investigator qualification and selection, scrutiny of potential patient recruitment, and overall study status/progress throughout the life of a study
Manage site start-up/activation process, including: Heavy contribution to the preparation of study-related documents (protocols, case report forms (CRFs) or eCRFs, draft informed consent forms (ICF) and complete checklists, able to help clinical trial agreements and budget negotiation, clinical monitoring plan)
Organizing IRB/EC submissions and applicable regulatory documentation with follow-through to ensure successful outcomes
Amends clinical study documents (ICF, CRFs, Monitoring Plan, etc…) as needed and helps clinical sites with institutional review board submission as necessary
Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits, and site close-out visits
Conduct clinical study 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
Serve as the main liaison to participating clinical trial sites, focusing on data entry, query resolution, investigational device tracking and accountability, and study conduct oversight at the participating clinical sites
Partner with data management to help the data cleaning process
Drive review of safety events and partner on developing narrative and reporting as needed
Develop and manage study trial master file 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.)
Track, process and manage site payments and help in study financial tracking by developing tracking tools as necessary
Assist the Clinical Study Manager on study scoping activities, including, but not limited to, the development of pre-study questionnaires, study design, and surgeon/site selection
Help site audits and site audit preparation in anticipation of site inspections
Mentor junior CRAs and CTAs on monitoring and other study needs
Qualification
Required
Previous experience implementing, helping and managing medical device trials
Significant knowledge of clinical and/or outcomes research study design
Possess advanced knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR Part 11, 50, 54, 812 and other applicable regulations
Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
Excellent ability to interact with physicians and other professionals inside and outside the company
Excellent experience in protocol and ICF development, writing clinical section(s) for regulatory submission
Experience negotiating clinical research contracts and budgets
Must be able to work effectively on cross-functional teams
Must be able to travel 25-40% or based on business requirements
Must be able to manage multiple projects and/or manage different 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 surgical specialties as applicable to clinical projects ('Self-starter attitude')
Ability to manage CRAs and CTAs and support management with relevant study updates
Exhibits solid work ethic to help meet tight timelines or multiple projects when necessary with a problem-solving mindset
Proficiency in Microsoft Office Suite, PDF application
Experience working with electronic data capture (EDC) systems required
Experience in medical device industry required
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 3 years' experience; or equivalent experience in a scientific field
Preferred
Clinical research/clinical trial management certification/education preferred
Prior experiences working in a clinical setting is preferred
Experience in clinical trial management systems preferred
Accustomed to working in a hospital environment, experience working with nurses and surgeons preferred
Knowledge of statistics, statistical methods, and design of experiment is highly preferred
Benefits
Market-competitive compensation packages
Incentives
Benefits
Equity
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
Represents job field similar to this job
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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