At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique.
As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare's complex challenges.
We believe a great idea can come from anywhere-inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential.
Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's help to advance the world of minimally invasive care.
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)
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.)
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.
Support payment and budget tracking of clinical sites and vendors
Prepare and ship site binders and patient binders as necessary
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 and provide administrative support including scheduling study and investigators meetings, distributing agendas and meeting minutes
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 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%
Intuitive is an Equal Employment 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.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.