Senior Clinical Trial Associate

General Description of 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.

Qualifications and 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.
• 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.

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!