Clinical Trial Operations Specialist – Onsite

Intuitive; Sunnyvale (CA); On-site; USD 70,000 - 94,800; Full time

Job summary

Intuitive Surgical Headquarters in Sunnyvale, CA seeks a Clinical Trial Assistant to provide operational support coordinating clinical studies and ensuring GCP compliance and regulatory alignment. You will manage study supplies, trial master file, and documentation, support budgets, and collaborate with CSM/CRA/CRAs to drive study execution while maintaining detailed records and timely communications.

This onsite role requires strong organizational skills, travel up to 10%, and a commitment to

Qualifications

• Excellent communication, organization and interpersonal skills with strong attention to detail.
• Strong ability to organize, prioritize and manage multiple priorities.
• Prior experience in medical device clinical trials, regulatory support, clinical project coordination.
• Proficient in MS Office suite, Adobe, video and web conferencing solutions.
• Clinically savvy with knowledge of basic medical terminology; good understanding of GCP/ISO 14155 and 21 CFR Part 812.

Responsibilities

• Coordinate and manage ordering, shipping, labeling, and tracking of study supplies with limited supervision.
• Maintain trial master file and TMF/case document management to ensure regulatory compliance.
• Support study budget tracking and payments to sites/vendors; assist with cost controls.
• Prepare and ship site/patient binders; create study informational materials and newsletters.
• Collaborate with CSM, CRA, and other study team members to ensure smooth study execution.

Skills

Communication

Organization

Clinical trials

MS Office

Regulatory knowledge

GCP/ISO 14155

Travel up to 10%

Education

Bachelor's degree (preferred)

High school diploma or equivalent

Clinical research certification/education (nice to have)

Tools

MS Office

Adobe

Video conferencing

Web conferencing

Job description

Intuitive Surgical Headquarters in Sunnyvale, CA seeks a Clinical Trial Assistant to provide operational support coordinating clinical studies and ensuring GCP compliance and regulatory alignment. You will manage study supplies, trial master file, and documentation, support budgets, and collaborate with CSM/CRA/CRAs to drive study execution while maintaining detailed records and timely communications.

This onsite role requires strong organizational skills, travel up to 10%, and a commitment to