Clinical Research Associate (CRA) III (Hybrid)

CVRx, Inc.; Brooklyn Park (MN); Hybrid; USD 127,000 - 142,000; Full time

Benefits offered by this job

Health & Dental Insurance

HSA contributions

401(k) match

ESPP & RSU grants

Company stock options

Holidays & generous PTO

Parental leave

Job summary

CVRx, Inc. is seeking a Clinical Research Associate III (CRAIII) to manage day-to-day operations of clinical trials and monitor sites to ensure compliance with the protocol, SOPs, and GCP.

The role collaborates with the Clinical Study Manager to meet project deliverables and can work from the CVRx office or at sites during monitoring. Ideal candidates will reside near our Brooklyn Park, MN headquarters with willingness for occasional on-site visits and up to 50% travel within the US to support

Qualifications

• Bachelor's degree required.
• Minimum of 5 years' experience directly supporting clinical research of an implantable medical device or similar medical/scientific area.
• Minimum of 2 years' experience in monitoring clinical trial sites.
• Deep knowledge of GCPs and regulatory guidelines for clinical trials.
• Excellent written and oral communication skills and ability to work cross-functionally.

Responsibilities

• Develops and maintains relationships with study sites; primary contact.
• Supports material preparation and investigator/site staff training.
• Monitors sites per plan to ensure protocol and regulatory compliance.
• Collects and tracks regulatory documents from sites.
• Verifies data accuracy and oversees data correction with site personnel.
• Prepares monitoring reports per study requirements.
• Contributes to TMF quality checks and trial documentation.

Skills

Clinical research

Site monitoring

GCP knowledge

Regulatory compliance

Medical terminology

Education

Bachelor's degree

Advanced degree preferred

Job description

Why work for CVRx?

CVRx pioneers’ unique therapies that harness and harmonize the body’s natural systems, benefiting society and making CVRx a universal role model in healthcare. We value our commitments to others and continue to overcome challenges through determination, collaboration and purpose. 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 Role

The Clinical Research Associate III (CRAIII) 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 CRAIII 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.

KEY DUTIES AND RESPONSIBILITIES

• 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
• Reviews center activation documentation
• 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
• Assists with successful conduct of assigned studies. This includes interfacing with representatives from key functional groups including Regulatory Affairs and Quality Assurance, Research & Development, U.S. 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
• Ability to pay high level of attention to details and accuracy
• Excellent at managing multiple tasks and able to operate independently
• Manage tasks and duties in an efficient and expedient manner
• Maintains a high personal standard for ethics and integrity
• Contributing team player with excellence in working cross-functionally while maintaining high-performance standards
• Comfortable in a small company and able to thrive in a high-growth environment
• Sophisticated written and oral communications skills
• Effective problem-solving skills
• Adaptable, resourceful, and comfortable navigating change
• Entrepreneurial approach
• 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 valid license and reliable transportation
• 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

WORKING CONDITIONS AND REQUIRED PHYSICAL EFFORT

• Normal office conditions and a reliable high speed internet connection required when working in a home office
• Must be able to sit/stand/walk 8 hours per day
• Position requires up to 40% travel across the U.S.
• May be required to be fully vaccinated against the COVID-19 virus and other diseases

CVRx is unable to provide employment visa sponsorship for this position. Candidates must be legally authorized to work in the United States without current or future sponsorship

What we offer

CVRx is proud to offer competitive salaries and benefits plans.

We offer a culture of teamwork, collaboration, and positivity, where challenging the status quo is welcomed, continuous learning is valued, and each of us has an opportunity to make a significant impact in an exciting, purpose-driven startup environment while also having fun.

Salary range for U.S locations (USD): 127,000 - 142,000 per year.

The pay range is applicable across the U.S., complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and specific location.

We also offer a competitive and rewarding benefits package, details listed below:

• Competitive Health & Dental Insurance options with generous Company contributions
• Company contributions to an HSA with a high deductible insurance plan selection
• 401(k) with a company match
• Employee stock purchase plan (ESPP) & stock option and RSU grants
• 12 company-paid holidays per year in addition to a generous Flex PTO plan
• Generous paid time off for new parents
• Company-paid life insurance & disability options
• Unlimited growth opportunities in a growing company
• Endless training & learning opportunities
• Flexible Schedule

EEO STATEMENT

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!

If you need assistance or an accommodation due to a disability, you may contact us at [e-mail]

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This requisition will be open until filled.