Senior Clinical Research Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• The Senior Clinical Research Associate is responsible for ensuring monitoring excellence, maintaining data integrity, and fostering site engagement throughout the entire lifecycle of a clinical study.

• Ensure compliance in study conduct, guarantee data reliability, and provide operational and clinical support to sites from initiation to close-out.

• Actively assist in enrollment and follow-up performance while collaborating with site teams on the clinical aspects of the work.

• Partner with internal clinical teams in executing the study to meet goals and milestones.

• Track subject enrollment progress across designated clinical study sites to ensure enrollment targets and timelines are achieved.

⛳️ Requirements

• A Bachelor's degree in life sciences, nursing, biomedical or electrical engineering, or a related scientific or technical discipline is preferred; an equivalent combination of education and professional experience is acceptable.

• A minimum of five years of experience in the medical device industry is required.

• At least five years of CRA experience on complex IDE or PMA studies, with a minimum of two years in a medical device setting, or a comparable mix of CRA and relevant clinical experience such as Study Coordinator, cardiac device clinic, or Field Clinical Engineering.

• Experience with Class III cardiovascular rhythm management (CRM) devices (e.g., pacemakers, ICDs, CRT-D) or equivalent implantable cardiovascular devices is highly preferred.

• Strong proficiency in clinical trial management (preferably in medical devices) along with a solid understanding of the CRA role and responsibilities.

• Familiarity with regulatory standards (ICH, GCDMP, 21 CFR 11, GDPR).

• Experience with web-based EDC, software tools (Microsoft Office Suite), Adobe, SharePoint, shared drives, and other custom web-based software for administrative purposes.

• Willing and able to travel up to 30%, including potential weekend and overnight trips as necessary.

🏝️ 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 advancement.

• Employee stock options.

• Life & AD&D and long-term disability insurance.

• Education assistance.

• Voluntary commuter benefits and pet insurance.

• Meaningful work and much more!