Senior Clinical Research Associate

🕒 May 8

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EBR Systems, Inc.

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51 - 200 employees

EBR Systems, Inc. is driven to deliver superior treatment for millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. The company’s initial product, the WiSE® CRT System, is a first-of-its-kind medical device developed to overcome the limitations of traditional Cardiac Resynchronization Therapy (CRT) in heart failure patients by eliminating the need for a lead to the heart’s left ventricle and the associated complications of that lead.

📋 Description

• The Senior Clinical Research Associate is accountable for monitoring excellence, data integrity, and site engagement across the full lifecycle of a clinical study. • Ensure studies are conducted compliantly, data are reliable, and sites are operationally and clinically supported from start-up through close-out. • Actively support enrollment and follow-up performance, and engage with site teams on the clinical substance of the work. • Collaborate with internal clinical teams in the execution of the study to achieve study goals and milestones. • Monitor subject enrollment progress across assigned clinical study sites to ensure enrollment targets and timelines are met.

🎯 Requirements

• Bachelor's degree in life sciences, nursing, biomedical or electrical engineering, or a related scientific or technical field preferred; an equivalent combination of education and professional experience is acceptable. • Five or more years of experience in the medical device industry required. • Five or more years of CRA experience on complex IDE or PMA studies, with at least two years in a medical device setting, or an equivalent combination of CRA and relevant clinical experience such as Study Coordinator, cardiac device clinic, or Field Clinical Engineering. • Class III cardiovascular rhythm management (CRM) device experience (e.g., pacemakers, ICDs, CRT-D) or equivalent implantable cardiovascular device experience is strongly preferred. • Strong expertise in clinical trial management (medical device preferred) and the CRA role and responsibilities. • Knowledge of regulatory standards (ICH, GCDMP, 21 CFR 11, GDPR) • Experience with web-based EDC, software tools (Microsoft Office Suite), Adobe, SharePoint, shared drive, and other custom web-based software used for administrative functions. • Willing and able to travel up to 30%, which may include weekend and overnight trips when appropriate.

🏖️ Benefits

• Medical, dental, and vision insurance provided at no cost for employee-only coverage • 401(k) matching plan • Paid Time Off – starting at 3 weeks per year • Competitive salary with opportunities for career growth • Employee stock options • Life & AD&D and long-term disability insurance • Education assistance • Voluntary commuter benefits and pet insurance • Meaningful work and much more!