Clinical Research Associate II

ABOUT INSPIRE MEDICAL SYSTEMS  Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation.  We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve. WHY JOIN OUR FAST-GROWING TEAM  At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.  If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team! POSITION SUMMARY  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 that clinical centers perform the clinical study according to the study protocol and regulatory standards by qualifying, training, monitoring, and overseeing study conduct at multiple clinical centers. MAIN DUTIES/RESPONSIBILITIES  Identify and assess the suitability of clinical study centers for participation in Inspire clinical trials.  Serve as a primary point of contact for study sites, investigators, and other stakeholders.  Train clinical centers on the clinical study protocol, data collection and good clinical practices.  Communicate directly with clinical centers to maximize enrollment, ensure quality and timely data capture and answer study-related questions.  Perform remote and on-site monitoring visits at participating clinical study centers to ensure the safety of study patients, the reporting of accurate study data and appropriate study management at the clinical study center. Ability to travel up to approximately 30% is required.  Document site visits by preparing visit reports and follow-up letters to the clinical study centers.  Facilitate effective communication and collaboration among study team members.  Assist clinical centers with the preparation of 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 train...