Capstan Medical, Inc.
Senior Clinical Trial Associate
Santa Cruz, California · Senior
Sponsorship not specifiedDetected 160 days ago
GCPStatisticsComplianceProject ManagementRoboticsClinical TrialsClinical ResearchMedical DevicesResearchExperimental DesignCommunicationProblem SolvingOrganizational SkillsMicrosoft Office
About the role
- 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.
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.
- Amend clinical study documents as needed and assist clinical sites with institutional review board submissions.
- 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.
Nice to have
- Bachelor's degree
- 1-3 years of monitoring experience is preferred.
Skills
- 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.
- 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.
- 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.
- 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.
- Proficiency in Microsoft Office Suite and PDF applications.
Benefits
- 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
Equal opportunity
- We are an equal opportunity employer.
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