Inspire Medical Systems Inc. Hiring for Sr. Clinical Research Associate at Golden Valley, Minnesota Full Time

Inspire Medical Systemshas 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! Position Summary: This position is responsible for the
initiation and oversight of clinical centers to ensure the successful
conduct of active clinical studies. The Sr. 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
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
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 Required Qualifications: 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 boards 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
844-672-4 57 or emailcareers@inspiresleep dot com. Inspire Medical
Systems participates in E-Verify. 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 an equal opportunity employer 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 [email protected].