SunnyvaleFull TimeHealthcare
Remotely
gcpclinical trial coordinationregulatoryvideo conferencingadobems officeiso 1415521 cfr part 812
Job Description
📋 Description
- The Clinical Trial Assistant will provide operational support to coordinate the conduct and
- Coordinate ordering, shipping, labeling and tracking of study supplies with limited supervision.
- Establish and maintain electronic study files and trial master files for regulatory and protocol
- Support study management with budget tracking and payments to sites/vendors.
- Prepare and ship site binders and patient binders as necessary.
- Collaborate with CSM/CRA to develop informational materials and support study execution.
🎯 Requirements
- Excellent communication, organization and attention to detail.
- Ability to prioritize and manage multiple priorities.
- Experience in medical device clinical trials, regulatory support, and clinical project coordination.
- Proficient in MS Office, Adobe, and video/web conferencing solutions.
- Knowledge of Good Clinical Practice (21 CFR) and ISO 14155; knowledge of 21 CFR Part 812 helpful.
- 2-4 years of clinical research experience; bachelor’s degree is a plus; related
🎁 Benefits
- Market-competitive compensation with base pay, incentives, benefits, and equity.
- Onsite work at Intuitive Surgical Seattle office; travel may be required.
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