Sr. Clinical Research Associate

Intuitive - Sunnyvale, CA

Full-time - Mid Level

Onsite - Sunnyvale, CA

Miscellaneous Manufacturing

About the position

The Senior Clinical Research Associate (Sr. CRA) at Intuitive plays a crucial role in managing pre-market and post-market clinical studies, ensuring compliance with regulatory requirements. This position involves collaboration with various stakeholders to execute clinical studies with minimal supervision, requiring a thorough understanding of clinical investigation protocols and regulations. The Sr. CRA will also mentor junior team members and contribute to the development of clinical study reports and publications.

Responsibilities

• Contribute to all clinical research activities to ensure the successful management of clinical studies.
• Maintain and track clinical study data and assist in investigator qualification and selection.
• Manage site start-up/activation processes, including preparation of study-related documents.
• Organize IRB/EC submissions and applicable regulatory documentation.
• Amend clinical study documents as needed and assist clinical sites with submissions.
• Perform on-site and remote site qualification visits and monitoring visits.
• Conduct clinical study monitoring to ensure regulatory and protocol compliance.
• Complete source data verification of clinical study data in EDC systems.
• Serve as the main liaison to participating clinical trial sites.
• Partner with data management to assist in the data cleaning process.
• Drive review of safety events and develop narratives and reports as needed.
• Develop and manage study trial master files and maintain study documentation.
• Track, process, and manage site payments and assist in financial tracking.
• Assist the Clinical Study Manager on study scoping activities.
• Help with site audits and preparation for inspections.
• Mentor junior CRAs and CTAs.

Requirements

• Minimum of 8 years of related experience with a BA/BS degree, or 6 years with a Nursing degree, Master's, MD, or PhD with 3 years of experience.
• Significant knowledge of clinical investigation of medical devices and Good Clinical Practice (ISO 14155, 21 CFR Part 11, 50, 54, 812).
• Experience in clinical trial management and protocol development.
• Excellent communication and relational skills with high attention to detail.
• Ability to manage multiple projects and priorities effectively.
• Proficiency in Microsoft Office Suite and experience with EDC systems.

Nice-to-haves

• Experience working in a hospital environment with nurses and surgeons.
• Knowledge of statistics and statistical methods.

Benefits

• Market-competitive compensation packages including base pay, incentives, benefits, and equity.