Description

We are seeking a Senior Clinical Research Associate to support clinical studies for Capstan Medical mitral and tricuspid valve products and to provide interim clinical support for the Versa Vascular tricuspid repair products. As a vital part of the Clinical Affairs team, you will collaborate with key stakeholders to execute clinical studies with minimal supervision. Close cooperation with research sites, engineering, regulatory teams, biostatisticians, and other departments will be essential for this role. The role is fast-paced and evolving, requiring excellent organizational and project management skills. Responsibilities include supporting clinical research activities, maintaining study data, managing CROs, overseeing site activation processes, ensuring regulatory compliance, and serving as the main liaison for clinical trial sites.

Requirements

A minimum of 5 years of medical device clinical trials experience. Bachelor’s degree; preferred clinical research/clinical trial management certification/education. Previous experience in managing and implementing cardiac medical device trials; 1-3 years of monitoring experience is preferred. 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. Experience in protocol and ICF development, writing clinical sections for regulatory submissions. Ability to manage CROs and provide relevant study updates to management. Experience with negotiating clinical research contracts and budgets. Experience with supporting or managing a clinical events committee and data safety monitoring board. 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.