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Reports to:Â Head/VP of Clinical
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At Capstan Medical, we’re driven by an unwavering commitment to transforming the treatment of heart valve disease. By merging surgical robotics with catheter-based technology and next generation implants, we’ve pioneered a patient-optimized approach to repair and replace heart valves.
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Our innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients with a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.
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Capstan Medical is uniquely positioned in Santa Cruz. This gives us access to the amazing technical talent of the Bay Area, but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.
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Come join us and become part of a team revolutionizing heart valve treatment!
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Description:
As a Medical Reviewer, you will work with internal cross-functional teams and external clinical partners to provide expert medical review of patient enrollment criteria for potential clinical study candidates and lead clinical study safety oversight. The role is fast-paced and evolving, requiring excellent organizational skills and deep understanding of cardiovascular and structural heart conditions. This is a hybrid role with the ability to travel to headquarters for training and collaboration.
\n- Review patient medical history along with screening team to confirm clinical study eligibility.Â
- Manage clinical safety oversight activities for clinical studies, including Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) coordination.
- Develop safety management plans, committee charters, Standard Operating Procedures, and processes for assigned studies.
- Review adverse events and coordinate activities with data management, regulatory affairs, and clinical affairs to ensure ongoing data quality and safety oversight.
- Develop adverse event narratives for safety committee review.
- Collaborate with investigators, research coordinators, and other clinical study site personnel on safety events.
- Collaborate with regulatory affairs to ensure timely reporting of applicable events.
- Advise on clinical protocol development and safety oversight in accordance with medical society guidelines.
- Create strategy for developing and maintaining clinical education materials, including updates to the materials.Â
- Review abstracts, manuscripts, and presentations for accurate representation of clinical safety data.
- Collaborates on other clinical affairs activities as needed.
- Strong interpersonal and communication skills and the ability to work effectively with internal stakeholders and clinical study site personnel.
- Exceptional project management and organizational skills.Â
- Clear and concise written communication skills.
- Skilled in the use of computers, Microsoft Suite of products.
- Strong work ethic to meet tight timelines and manage multiple projects with a problem-solving, collaborative mindset.
- MD or a licensed RN or equivalent.
- Minimum of 10 years of relevant medical device clinical experience.
- Knowledge of FDA guidelines and other relevant geographical regulations.
- Ability to travel and work onsite in Santa Cruz as neededÂ
- Ability to work outside the Monday-Friday, 9am-5pm schedule, especially to account for travel and different geographies
Why Join Us:
- We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space that can make a meaningful impact for patients
- We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off
- We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, and disability, or other legally protected status.
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