Senior Clinical Research Associate 3 — Onsite Trials

Intuitive; Sunnyvale (CA); Hybrid; USD 99,000 - 116,000; Full time

Job summary

Intuitive is seeking a Clinical Research Associate to drive pre-market and post-market clinical studies with strict regulatory compliance (ISO 14155, CFR 812) and collaboration across clinical affairs, data management, and biostatistics. You will help manage study documents, budgets, and site activities while ensuring high-quality data and patient safety.

The ideal candidate has extensive experience in medical device trials, solves problems quickly, and communicates clearly with physicians and

Qualifications

• Minimum 6 years of related experience with a BA/BS or 4 years plus advanced degree.
• Strong knowledge of ISO 14155, 21 CFR Part 11, 50, 54, 812 and related regulations.
• Experience negotiating clinical research contracts and budgets.

Responsibilities

• Assist in pre-market and post-market clinical studies.
• Maintain and track study data and support investigator site qualification and recruitment.
• Lead site start-up/activation, regulatory submissions, and monitoring visits.
• Coordinate with data management for data cleaning and query resolution.
• Prepare study master file and regulatory documents; manage budget tracking.
• Support site audits and regulatory inspections as needed.

Skills

Clinical research

GCP knowledge

Regulatory compliance

Communication

Education

BA/BS + 6 years experience

Nursing/MD/PhD advanced degree

Tools

EDC systems

Clinical trial management systems

Job description

Intuitive is seeking a Clinical Research Associate to drive pre-market and post-market clinical studies with strict regulatory compliance (ISO 14155, CFR 812) and collaboration across clinical affairs, data management, and biostatistics. You will help manage study documents, budgets, and site activities while ensuring high-quality data and patient safety.

The ideal candidate has extensive experience in medical device trials, solves problems quickly, and communicates clearly with physicians and