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