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 Study Associate will play a key role in providing operational support to coordinate the conduct and (data) 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 and Responsibilities:
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), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget)
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 Project Managers to support study execution and provide administrative support including scheduling study and investigators meetings, distributing agendas and meeting minutes
Responsible for data trial data management, and working with documentation specialist to archive and store clinical trial data
Perform analysis on clinical trial data, and summarizing results in study reports
Monitor and report project status for milestones, documentation, and deliverables.
Author and assist in the development of preclinical and clinical documents including but not limited to protocols and amendments, Investigator’s Brochures, IRB applications, informed consent forms, statistical analysis plans (SAP), medical (MMP) and clinical (CMP) monitoring plans, IND submissions, clinical trial master files (TMFs), annual reports and preclinical and clinical study reports
Design and assist in the development and review of case report forms (CRFs), electronic data capture strategies (eDC with eCRFs) and clinical study databases
Data entry into Electronic Data Capture (EDC) systems
Coordinate and manages ordering, shipping, labeling and tracking of study supplies (including investigational products)
Skills, Experience, Education, & Training:
Excellent communication, organization and interpersonal skills with strong attention to detail
Minimum Bachelor’s degree, Masters or PhD is a plus
Strong ability to organize, prioritize and manage multiple priorities
Prior experience in medical device clinical trials, regulatory support, clinical project coordination is preferred
Clinically savvy and good knowledge of basic medical terminology is 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.
Research/clinical trial management certification/education is a plus
Proficient in MS Office suite, Adobe, video and web conferencing solutions
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.
Shift : Shift 1 - Day
Travel : Yes, 25 % of the Time
Intuitive Surgical, Inc.
Intuitive Surgical, Inc.