Capstan Medical · 11 hours ago
Senior Clinical Research Associate
Santa Cruz County, CA
Full-time
Hybrid
Senior Level
5+ years expCapstan Medical is committed to transforming the treatment of heart valve disease through innovative technology. The Senior Clinical Research Associate will support clinical studies for mitral and tricuspid valve products, collaborating with various stakeholders and managing clinical research activities to ensure effective study management.
MedicalMedical DeviceRobotics
Responsibilities
Support clinical research activities to ensure effective management of clinical studies
Maintain and track clinical study data, assist in investigator qualification and selection activities, monitor patient recruitment, and oversee study progress
Manage clinical research organizations (CRO) involved with the study
Oversee site start-up/activation processes, including preparing study documents such as protocols, CRFs/eCRFs, informed consent forms, and clinical monitoring plans
Organize IRB/EC submissions and ensure regulatory compliance for successful outcomes
Amend clinical study documents as needed and assist clinical sites with institutional review board submissions
Support on-site and remote site qualification, initiation, monitoring, and close-out visits
Serve as the main liaison for participating clinical trial sites, focusing on data entry, query resolution, investigational device tracking, and accountability
Schedule safety event reviews and develop necessary narratives and reports. Support management of CEC and DSMB if applicable
Manage trial master file, maintain study documentation, and clinical trial management systems
Track and process site payments, develop tracking tools as necessary, and assist in study financial tracking
Develop, administer, track and archive pre-study questionnaires
Qualification
Required
A minimum of 5 years of medical device clinical trials experience
Bachelor's degree; preferred clinical research/clinical trial management certification/education
In-depth knowledge of clinical research study design and medical terminology
Advanced knowledge of Clinical investigation of medical devices for human subjects, including ISO 14155, 21 CFR Part 11, 50, 54, 812, ICH/GCP guidelines, and other relevant regulations
Strong ability to interact with physicians and professionals inside and outside the company
Ability to manage CROs and provide relevant study updates to management
Experience with electronic data capture (EDC) systems
Knowledge of statistics and statistical methods
Ability to work effectively on cross-functional teams and manage multiple projects and priorities
Excellent communication, presentation, and organizational skills with high attention to detail
Ability to learn quickly and self-educate on various surgical specialties applicable to clinical projects
Strong work ethic to meet tight timelines or manage multiple projects with a problem-solving mindset
Proficiency in Microsoft Office Suite and PDF applications
Ability to work onsite in Santa Cruz as needed
Preferred
Previous experience in managing and implementing cardiac medical device trials; 1-3 years of monitoring experience is preferred
Experience in protocol and ICF development, writing clinical sections for regulatory submissions
Experience with negotiating clinical research contracts and budgets
Experience with supporting or managing a clinical events committee and data safety monitoring board
Company
Capstan Medical
Capstan Medical is creating minimally invasive technologies to treat heart valve disorders.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$141.4MKey Investors
Eclipse Ventures
2024-12-11Series C· $110M
2023-08-09Series B· $31.4M
Leadership Team
Dan Wallace
Founder & CTO at Capstan Medical
Recent News
2026-01-07
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