Reports to: Head/VP of Clinical

At Capstan Medical, we’re building one of the most exciting and innovative companies in medtech—developing a first-of-its-kind robotic platform for minimally invasive heart valve treatment. Our team combines surgical robotics, catheter-based delivery, and next-generation implants to transform complex procedures into safer, lower-stress solutions for patients and clinicians alike. As a highly collaborative, hands-on team, we move fast, wear multiple hats, and believe the best ideas can come from anyone.

Based in Santa Cruz, our unique workspace blends cutting-edge Bay Area innovation with a lifestyle-driven environment near trails, beaches, and open space—creating the perfect place to do meaningful, career-defining work.

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.

Role:

Review patient medical history along with screening team to confirm clinical study eligibility.
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.
Review abstracts, manuscripts, and presentations for accurate representation of clinical safety data.
Collaborates on other clinical affairs activities as needed.

Skills:

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.
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.

Requirements:

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 needed
Ability to work outside the Monday-Friday, 9am-5pm schedule, especially to account for travel and different geographies