Intuitive Surgical Careers

Clinical Research Associate - IDE

US-CA-Sunnyvale, California
Clinical Affairs

Job Description

Job: Clinical Affairs
Primary Location: United States-California-US-CA-Sunnyvale
Schedule: Full-time
Requisition ID: 182403


Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.

Primary Function of Position:

The Clinical Research Associate will report to Manager, Clinical Affairs, and will play a key role to proactively support the conduct of pre-market clinical studies to ensure compliance with all the regulatory requirements. The ideal candidate will have thorough knowledge of Good Clinical Practices (GCP) and applicable regulations.

Key responsibilities:

• Support all clinical research activities essential to the successful management of pre market clinical studies under the direct supervision of clinical project manager or clinical affairs manager.
• Maintain and track data of the clinical studies including investigator selection, analysis of potential patient recruitment, and overall study status/progress throughout the life of a study.
• Manage site start-up/activation process, including: contributing to the preparation of study related documents (protocols, case report forms/eCRFs, informed consent forms, clinical trial agreements, budgets, clinical monitoring plan), organizing IRB/EC submissions and applicable regulatory documentation with follow through to ensure successful outcomes.
• Amends clinical study documents as needed.
• Collaborate with data management to ensure data cleaning process is performed and perform source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a paper case report form at sites to ensure regulatory and protocol compliance and overall accuracy.
• Serve as main liaison to participating clinical trial sites with focus on data entry, query resolution, and overall site activity
• Conduct clinical study on-site monitoring in accordance with the clinical monitoring plan.
• Provide project administrative support including maintenance of study documentation (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 .
• Assist Clinical Project Managers on study scoping activities, including but not limited to development of pre-study questionnaires, study design and surgeon/site selection
• Perform site audits in preparation for site inspections
• Maintain trial master file essential documents and clinical trial management system

Competency Requirements: 

(Competency is based on: education, training, skills and experience.)In order to adequately perform the responsibilities of this position the individual must: 

• Possess basic knowledge of Good Clinical Practice and 21 CFR Part 11, 50, 54, 812 and international regulations
• Bachelor’s degree in scientific field required
• 5 years of experience in clinical trial operations and monitoring preferred
• Clinical research/clinical trial management certification/education preferred
• Must be clinically savvy and possess time management, organizational skills and problem-solving skills.
• Excellent written and oral communication skills, problem-solving skills and interpersonal skills with high attention to detail and organization
• Ability to work successfully in a team environment and ability to prioritize and manage multiple tasks as necessary.
• Proficiency in Microsoft Office, including Word, PowerPoint, Visio and Excel
• Experience working with electronic data capture systems
• Experience in medical device industry required
• Must be able to travel up to 30%
Ability to multi-task and work in a dynamic environment with simultaneous projects/tasks

We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.