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 mostly remote.
Please note that our ideal candidates will reside near our headquarters in Brooklyn Park, MN and be open to occasional on-site visits for meetings as required.
Please note that this position requires travel up to 50% as needed to support monitoring in sites across the US.
The Clinical Research Associate III (CRA III) will be responsible for the day-to-day operations associated with the execution of clinical trials and monitoring the clinical trial sites to ensure they are complying to the applicable study protocol, Standard Operating Procedures (SOPs), CVRx requirements, Good Clinical Practice (GCP), and the applicable regulatory requirement(s). The CRA III will work closely with the Clinical Study Manager to ensure site day-to-day operations and monitoring is executed to meet project deliverables. CRA III is expected to work from the CVRx office, or at the sites when monitoring.
\Develops and maintains successful working relationships with study sites and serves as the primary point of contact.
Assists in preparation of study materials and training of investigators and site staff
Supports Clinical Centers in the execution of site IRB or ethics committee submissions
Responsible for the collection and tracking of required regulatory documents from Clinical Centers
Coordinates and conducts monitoring (as directed by the monitoring plan) at participating centers to ensure compliance with the protocol and applicable regulations, as well as the timely receipt of accurate data and other required study documents
Prepares and submits high-quality monitoring reports per study-specific requirements
Evaluate site performance through analysis of enrollment trends, data quality metrics, protocol deviations, product accountability, and patient safety parameters
Support sites in AE/SAE identification, documentation, and reporting
Verify timely submission of required safety documentation, device complaint forms, and follow-up queries
Drive proactive risk identification at the site level and support the execution of risk-mitigation plans
Source verifies clinical data/information and oversees data correction to match source
Maintains Clinical Study files
Manages device accountability at site (if applicable)
Processes payments to sites, vendors, and consultants
Reviews clinical data/information and oversees data correction
Work closely with Clinical Project Managers, Data Management, Safety, Regulatory, Quality, and Training to ensure end-to-end study execution
Provide operational input on protocol development, CRFs, risk assessments (RACT), monitoring plans, investigational brochures, and essential document requirements
Collaborate in Trial Master File (TMF) quality checks to ensure site-level documentation is complete, audit-ready, and compliant
Contribute to process improvement initiatives, QMS updates, and clinical operations optimization
Assist management in metrics reporting, monitoring dashboards, and early risk detection through data analytics
Participate in vendor oversight (central labs, imaging, core labs) to ensure site compliance (if applicable)
Assists in training new Clinical Research Associates
This includes interfacing with representatives from key functional groups including Regulatory Affairs and Quality Assurance, Research & Development, U.Market Development, Commercial Development and Clinical Research Organizations
Provides mentoring regarding site monitoring to internal team
Completes special projects and performs job-related duties as assigned
REQUIRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE
Bachelor’s degree
Minimum of 5 years’ experience directly supporting clinical research of an implantable medical device or similar experience in a medical/scientific area
Minimum of 2 years’ experience in monitoring clinical trial sites
Deep knowledge of GCP’s and regulatory compliance guidelines for clinical trials
Effective comprehension of medical terminology
Maintains a high personal standard for ethics and integrity
Contributing team player with excellence in working cross-functionally while maintaining high-performance standards
Must be able to travel up to 40% within the US by car and air
Must possess valid government ID for domestic air travel (i.e. Passport, etc.)
Must have a professional home-office environment in which to perform work from home (when permitted) in a confidential and private manner
PREFERRED EDUCATION, TRAINING AND JOB-RELATED EXPERIENCE
~ Advanced degree in a related field is preferred

Normal office conditions and a reliable high speed internet connection required when working in a home office
Position requires up to 40% travel across the U.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 RSU 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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