Clinical Research Monitoring (CRA)

CVRx pioneers' unique therapies that harness and harmonize the body’s natural systems, benefiting society and making CVRx a universal role model in healthcare. If our culture and values speak to you, and if you have a passion for cutting-edge medical technologies, join our team and our mission to help others live better lives.
This position is hybrid onsite at our Brooklyn Park, MN headquarters and our ideal candidate will reside locally.
The Clinical Research Associate (CRA) II performs the day-to-day operations associated with the execution of clinical trials and is responsible for the direct contact with assigned clinical investigative sites. The CRA II will coordinate site activities from site start-up to site closure as needed. The CRA II will ensure the overall quality of the clinical sites by reviewing study data and managing site adherence to the protocol, Good Clinical Practice (GCP), and all applicable regulations. The CRA II will work closely with the other CRAs on the clinical team and project managers to ensure the sites maintain compliance.
\Develops and maintains successful working relationships with study sites and CVRx field staff
Assists in preparation of study materials and training of investigators and research site staff
Becomes proficient with all study databases, systems and company quality management system
Reviews and verifies clinical data/information and oversees data correction to match source
Acts a site manager and monitor to assigned sites as applicable per study requirements
Processes payments to sites, vendors, and consultants. Supports the Clinical Project Manager with study finance activities and tracking
Supports Clinical Centers in the execution of site Institutional Review Board (IRB) or ethics committee (EC) submissions
Responsible for the collection, tracking, and maintaining required study and regulatory documents from clinical centers through all phases of assigned projects
Prepares study materials and trains investigators and site staff
Responsible for shipment of study-related materials as applicable
Coordinates and conducts monitoring (as directed by the monitoring plan) at participating centers to ensure compliance with protocol, regulations, and the timely receipt of accurate data / other required study documents
Reviews and verifies clinical data/information and oversees data correction to match source
Reviews monitoring reports
Manages device accountability at site (if applicable)
Provides input to study budgets and project plan
Contributes to maintaining oversight of activities conducted by Contract Research Organizations (CRO’s) or other contractors on behalf of CVRx (if applicable)
Assists in training or mentorship of new Clinical Research Associates
Completes special projects and performs job-related duties as assigned

REQUIRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE
Bachelor’s degree or advanced degree in science or a related field, or equivalent work experience
2-4 years experience directly supporting clinical research or similar experience in a medical/scientific area
Knowledge of medical terminology
Experience with GCP’s and regulatory compliance guidelines for clinical trials
Creative and resourceful
Team player with high performance standards
PREFERRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE
Advanced degree in a related field

Normal office conditions
Position requires up to 40% travel
May be required to be fully vaccinated against the COVID-19 virus and other diseases.

\complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and specific location.
Competitive Health & Dental Insurance options with generous Company contributions

• Employee stock purchase plan (ESPP) & stock option and restricted stock unit grants
• 12 company-paid holidays per year in addition to a generous Flex PTO plan
• Company-paid life insurance & disability options
• Unlimited growth opportunities in a growing company
• Endless training & learning opportunities
• Flexible Schedule

CVRx, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
If you're an independent, self-motivated individual with excellent interpersonal skills, a desire to do great things and have a background in medical devices, healthcare or a related field, we want to hear from you!
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