- Identify and assess the suitability of clinical study centers for participation in Inspire clinical trials
- Train clinical centers on the clinical study protocol, data collection and good clinical practices
- Site Management; Communicate directly with clinical centers to maximize enrollment, ensure quality and timely data capture and answer study-related questions
- Assist in mentoring Junior monitors
- 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
- Document site visits by preparing visit reports and follow-up letters to the clinical study centers
- 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
- Document product and therapy field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed
- Complete training requirements and competency confirmations as required for this position within the required timeline
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement
- High School Diploma or GED required
- Bachelor's Degree (BA or BS) preferred; Science Degree preferred
- Previous experience in clinical research (minimum 3 -5 years required)
- Previous training and understanding of GCP and 21 CFR 812 required
- Ability to report on-site to Golden Valley, MN office required
- Ability to travel up to approximately 30% required
- Experience with clinical study documentation, clinical data and data capture institutional review boards
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Clinical Research Associate - Golden Valley, United States - Inspire Medical Systems, Inc.
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 TEAMAt 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 teamABOUT THIS POSITION
This position is responsible for the initiation and oversight of clinical centers to ensure the successful conduct of active clinical studies.
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.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
Required Qualifications:
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 or email (dot)com
Inspire Medical Systems participates in E-Verify.
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Clinical Research Associate professionals in Minneapolis
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Durgadevi Hariharan
Virology Research Scientist
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Dr. Mahad Ibrahim
MD | PGOBGYN | Healthcare Analyst
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Ninad Khade
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