Clinical Trial Assistant

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description

Primary Function of Position:

The Clinical Trial Assistant will play a key role to provide operational support to coordinate the conduct and management of clinical studies to ensure compliance with Intuitive standard operating procedures, Good Clinical Practices (GCP), good documentation practices, and applicable regulations. The ideal candidate will have good understanding of clinical trials regulatory requirements. This position is based at the Intuitive Surgical Headquarters in Sunnyvale, California.

Roles & Responsibilities:

• Coordinate and manage the ordering, shipping, labeling and tracking of study supplies (including investigational products) with limited supervision
• Establish, organize and maintain trial master file and clinical trial management system to ensure regulatory and protocol compliance including maintenance of study essential documentation (e.g., correspondence, CRFs, study approval documents, curriculum vita, etc…), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.)
• Contribute to operational excellence and continuous improvement
• Maintain, track and facilitate routing for approval and signature of clinical study documents including protocols, case report forms, Informed consents, Clinical trial agreements, non-disclosure agreements, etc
• Create purchase requests and process invoices
• Support clinical study manager with study budget tracking and payments of clinical sites and vendors
• Prepare and ship site binders and patient binders as necessary
• Contribute to creating clinical study informational materials such as newsletters, recruitment materials, etc.
• Collaborate with Clinical Study Managers (CSM) to develop clinical study informational materials such as newsletters, recruitment materials, etc
• Collaborate with Clinical Research Associates (CRA), Clinical Study Managers (CSM) and Clinical Managers to support study execution
• Provide administrative support to coordinate, schedule and plan study and investigators meetings, teleconferences, distributing agendas and meeting minutes

Qualifications

Skills, Experience, Education, & Training:

• 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 & good knowledge of basic medical terminology preferred
• Possess working knowledge of Good Clinical Practice as detailed in 21CFR and ISO 14155, and regulation such as 21 CFR Part 812
• Minimum of 2-4 years of related experience in clinical research with high school diploma or secondary education or equivalent
• Minimum Bachelor’s degree is a plus
• Research/clinical trial management certification/ education is a plus
• Able to travel up to 10%
• We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits and equity, and the anticipated pay rate for this position is $70,000 to $94,800
• It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including location, skills, and experience level

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.