Sr. Clinical Research Associate

Company Description

At Intuitive, we are united behind our mission: 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.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world 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 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 advance the world of minimally invasive care.

Job Description

Primary Function of the Position

The Senior Clinical Research Associate will play a key role in proactively helping the conduct of pre-market and post-market clinical studies to ensure compliance with all the regulatory requirements. The ideal candidate will have a 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. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies (pre-market or post-market studies) with minimal supervision. The candidate will be required to work closely with clinical study managers, clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, contribute to clinical study reports, or help the development of clinical publications. The candidate is also expected to have experience reviewing, interpreting, and summarizing clinical literature.

Essential Job Duties

• Contribute to all clinical research activities to ensure the successful management of clinical studies.
• Maintain and track clinical study data and help in investigator qualification and selection, scrutiny 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 help 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 helps 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 and 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 the main liaison to participating clinical trial sites, focusing on data entry, query resolution, investigational device tracking and accountability, and study conduct oversight at the participating clinical sites.
• Partner with data management to help the data cleaning process.
• Drive review of safety events and partner on developing 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 help in study financial tracking by developing tracking tools as necessary.
• Assist the Clinical