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Senior Clinical Research Associate
EBR Systems, Inc.Senior Clinical Research Associate ensuring data integrity and compliance throughout clinical study lifecycles. Driving site engagement and supporting enrollment in cardiovascular rhythm management studies.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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!
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementCRA experiencemedical device experienceIDE studiesPMA studiescardiovascular rhythm management devicesdata integritysite engagementenrollment performanceregulatory standards
Soft Skills
collaborationcommunicationmonitoring excellenceorganizational skillsproblem-solving