Clinical Research Associate II

Inspire Medical Systems I; Minneapolis (MN); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Health insurance

401k matching

Tuition reimbursement

Flexible time off

Employee stock purchase program

Job summary

Inspire Medical Systems is seeking a Clinical Research Associate to initiate and oversee multiple clinical centers, ensuring studies are conducted per protocol and regulatory standards. You will train sites, monitor enrollment and data quality, and travel up to ~30% to on-site centers.

Required: 3+ years in clinical research, GCP knowledge, and experience with IRB submissions. Competitive benefits and relocation support may be provided.

Qualifications

• Minimum 3 years of clinical research experience.
• Understanding of GCP and 21 CFR 812.
• Experience with clinical documentation and IRBs.
• Willingness to travel up to 30%.

Responsibilities

• Identify suitable clinical study centers for participation.
• Serve as primary contact for study sites and investigators.
• Train centers on protocol, data collection, and GCP.
• Monitor centers to ensure safety and data quality; travel up to 30%.
• Document site visits with reports and letters to centers.
• Coordinate with study team and IRB submissions.

Skills

GCP knowledge

Regulatory understanding

Clinical monitoring

Travel readiness

Education

High School Diploma or GED

Bachelor's Degree preferred

Science Degree preferred

Job description

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.

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 positionis responsible forthe 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 training materials and other study-related documentation.
• Maintain clinical monitoring tracking tools for each clinical study.
• Assist with other clinical related duties as assigned.

QUALIFICATIONS

Educational Requirements:

• High School Diploma or GED required
• Bachelor's Degree (BA or BS) preferred
• Science Degree preferred

Required Experience:

• Previous experience in clinical research (minimum 3 years)
• Understanding of GCP and 21 CFR 812
• Experience with clinical documentation, clinical data and institutional review boards

#LI-Onsite

The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.

$85,000 - $105,000 USD

BENEFITS AND OTHER COMPENSATION

Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):

• Multiple health insurance plan options.
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off.
• Tuition Reimbursement.
• Employee Assistance program.
• All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.

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, pregnancy or childbirth, 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.