Clinical Study Coordinator

Job Description

Job Description

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.

Our focus on patient outcomes is at the core of everything we do, and our think I can attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

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 hybrid work schedules, 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!

ABOUT THIS POSITION

The Clinical Study Coordinator will work directly with the clinical study managers and other clinical research personnel to assure the successful conduct of active studies, as well as satisfying applicable regulatory standards and Inspire internal requirements for clinical studies.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• Create, maintain, and manage the Trial Master File and Investigator Site Files for clinical studies
• Assist with the site qualification process by distributing surveys / tracking results as well as coordination of site qualification discussions and management of site qualification documentation
• Track site activation progress by ensuring receipt of proper study documentation including clinical trials agreements, IRB / MEC approvals, and training documents
• Actively participate in the design, development and user testing of study source worksheets and clinical study databases
• Create and review invoices related to study site payments; track clinical study payments and accruals
• Prepare, distribute, and track study materials (e.g. patient binders, regulatory binders, patient materials)
• Assist with submissions to central IRBs
• Perform periodic audits of clinical study files
• Perform study tracking as requested by clinical study managers
• Support other clinical projects / duties as needed

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required :

• High School Diploma or GED required
• Understanding of GCP and 21 CFR 812

Preferred :

• Bachelor’s Degree (BA or BS) preferred
• Science Degree preferred
• Previous experience in clinical research preferred
• Experience with clinical documentation, clinical data and institutional review boards preferred

Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state, and local laws.

This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs.

Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities.

All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce.

Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com

Inspire Medical Systems participates in E-Verify.