Inspire Medical Systems
has developed the only FDA-approved neurostimulation technology that transforms the lives of people with moderate to severe sleep apnea. We are a ground-breaking, fast-growing company where the patient's outcome is first and foremost our top priority. If you want to become part of a purpose-driven company and directly help to transform lives, this is the perfect career opportunity for you!
This position is responsible for the initiation and 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 AND RESPONSIBILITIES
* 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
* 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
* 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
QUALITY SYSTEM RESPONSIBILITIES
* 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 years)
* Understanding of GCP and 21 CFR 812
*Experience with clinical documentation, clinical data and institutional review board
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 with regard to 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 anemployer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at 763-235-6742 or email careers@inspiresleep dot com.
Inspire Medical Systems participates in E-Verify.