Clinical Research Associate II

About the Company

Inspire Medical Systems is the pioneer of a first-of-its-kind medical device designed to improve the lives of individuals living with Obstructive Sleep Apnea (OSA). We are transforming the sleep industry with our FDA-approved medical device, offering an alternative for those who cannot tolerate or do not benefit consistently from CPAP. Our commitment is to enhance patient lives through innovative sleep solutions, prioritizing patient outcomes, integrity, and respect.

Why Join Us

At Inspire, we value diverse experiences, backgrounds, and perspectives. We foster a people-first culture with excellent benefits, including 401k matching, Employee Stock Purchase Plan (ESPP), flexible time off (FTO), and tuition reimbursement. If you are passionate about making a difference in people’s lives and working with cutting-edge technology, we invite you to join our team.

About the Role

This position is responsible for the initiation and independent oversight of clinical centers to ensure the successful conduct of active clinical studies. The Clinical Research Associate will ensure clinical centers adhere to the study protocol and regulatory standards by qualifying, training, monitoring, and overseeing study conduct at multiple sites.

Responsibilities

• Identify and assess the suitability of clinical study centers for participation in Inspire clinical trials.
• Serve as the primary point of contact for study sites, investigators, and other stakeholders.
• Train clinical centers on the study protocol, data collection, and good clinical practices.
• Communicate with clinical centers to maximize enrollment, ensure quality and timely data capture, and address study-related questions.
• Perform remote and on-site monitoring visits to ensure patient safety, accurate data reporting, and proper study management. Travel up to approximately 30% is required.
• Document site visits by preparing reports and follow-up letters for clinical study centers.
• Facilitate effective communication and collaboration among study team members.
• Assist clinical centers with IRB/EC submissions.
• Collect and archive study-related documentation and correspondence.
• Communicate monitoring and site management updates to the internal clinical team.
• Assist with the development of the clinical study Monitoring Plan.
• Develop training materials and other study-related documentation.
• Maintain clinical monitoring tracking tools for each study.
• Assist with other clinical-related duties as assigned.

Requirements

• High School Diploma or GED (required).
• Bachelor’s Degree (BA or BS) preferred; Science Degree preferred.
• Minimum of 3 years of experience in clinical research.
• Understanding of Good Clinical Practice (GCP) and 21 CFR 812.
• Experience with clinical documentation, clinical data, and institutional review boards.

Pay

Salary range: $85,000—$105,000 USD. The final offer may vary based on geographic location, work experience, education, and skill level.

Benefits

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account (HSA).
• Dental, vision, life, and disability benefits.
• 401k plan with employer match.
• Identity protection.
• Flexible time off (FTO).
• Tuition reimbursement.
• Employee Assistance Program (EAP).
• Opportunity to participate in equity awards and the Employee Stock Purchase Program (ESPP).