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 Research Associate – Level 3 will report to Manager, Clinical Affairs, and will play a key role to proactively support the conduct of pre-market and post-market clinical studies to ensure compliance with all the regulatory requirements. The ideal candidate will have thorough knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR part 812, 50, 54, and other applicable regulations.
Roles & Responsibilities:
- Contribute to all clinical research activities to ensure successful management of clinical studies under the direct supervision of Clinical Affairs manager with dotted lines to clinical study manager.
- Maintain and track clinical study data and support in investigator qualification and selection, analysis of potential patient recruitment, and overall study status/progress throughout the life of a study.
Manage site start-up/activation process, including:
- Heavy contribution to the preparation of study related documents (protocols, case report forms (CRFs) or eCRFs, draft informed consent forms (ICF) and complete checklists, able to support in clinical trial agreements and budget negotiation, clinical monitoring plan),
- Organizing IRB/EC submissions and applicable regulatory documentation with follow through to ensure successful outcomes.
- Amends clinical study documents (ICF, CRFs, Monitoring Plan, etc…) as needed and support clinical sites with institutional review board submission as necessary.
- Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits
- Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring plan.
- Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a 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, investigational device tracking and accountability, and study conduct oversight at the participating clinical sites.
- Collaborate with data management to support data cleaning process
- Lead review of safety events and collaborate on development of narrative and reporting as needed
- Develop and manage study trial master file and maintain study documentation and clinical trial management system (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 and support in study financial tracking by developing tracking tools as necessary.
- Assist Clinical Study Manager on study scoping activities, including but not limited to development of pre-study questionnaires, study design and surgeon/site selection
- Support site audits and site audit preparation in anticipation of site inspections.
Skills, Experience, Education, & Training:
- Possess advanced knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR Part 11, 50, 54, 812 and other applicable regulations
- Minimum Education: Bachelor’s degree in scientific field required
- Minimum 5 years of experience in clinical trial operations and monitoring preferred
- Clinical research/clinical trial management certification/education preferred
- Prior experiences working in a clinical setting is preferred
- Must be clinically savvy and possess time management, organizational skills and problem-solving skills.
- Excellent written and oral communication skills and interpersonal skills with high attention to detail
- Ability to work successfully in a team environment and ability to prioritize and manage multiple tasks as necessary.
- Proficiency in Microsoft Office Suite, PDF application
- Experience working with electronic data capture (EDC) systems required
- Experience in clinical trial management systems preferred
- Experience in medical device industry required
- Must be able to travel up to 40%
- Ability to multi-task and work in a dynamic environment with simultaneous projects/tasks
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, 50 % of the Time
Travel Requirements: Yes, 50 % of the Time Shift: Shift 1 - Day
This job has expired.