Clinical Research Associate (CRA) III (Hybrid)

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

Benefits offered by this job

Health & Dental Insurance

HSA contributions

401(k) match

Employee stock purchase plan

RSU grants

12 holidays + generous PTO

Job summary

CVRx, Inc. is seeking a Clinical Research Associate III (CRAIII) to manage day-to-day trial monitoring and site coordination, ensuring adherence to the study protocol, SOPs, GCP, and regulatory requirements.

The CRAIII will support the Clinical Study Manager and may work from the CVRx office or at sites during monitoring. Ideal candidates have a Bachelor’s degree, 5+ years in implantable device clinical research, 2+ years monitoring sites, and strong regulatory knowledge.

Qualifications

• Deep knowledge of GCPs and regulatory compliance guidelines for clinical trials.
• Excellent written and oral communication for regulatory submissions.
• Ability to manage multiple tasks with attention to detail and independence.

Responsibilities

• Develop and maintain relationships with study sites and serve as primary contact.
• Assist in preparation of study materials and training of investigators and site staff.
• Coordinate monitoring visits to ensure protocol and regulatory compliance.
• Prepare monitoring reports and track data quality and enrollment trends.
• Support AE/SAE identification, documentation, and reporting.
• Collaborate with cross-functional teams to ensure end-to-end trial execution.

Skills

Regulatory knowledge

Clinical monitoring

Document management

Education

Bachelor’s degree

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

TheClinical Research AssociateIII(CRAIII) will be responsible for the day-to-day operations associated with the execution of clinical trials and monitoringthe clinical trial sitesto ensure they arecomplyingto the applicable study protocol, Standard Operating Procedures (SOPs), CVRxrequirements, GoodClinicalPractice (GCP), and the applicable regulatory requirement(s). The CRAIIIwill work closely withtheClinical Study Manager to ensure siteday-to-day operations andmonitoring 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 andserves asthe primary point of contact.
• Assists in preparation of study materials and training of investigatorsand sitestaff
• 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 andother 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 verifiesclinical data/information and oversees data correctionto 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 correctionReviews 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 Affairsand Quality Assurance,Research & Development, U.S. Market Development, Commercial Developmentand Clinical Research Organizations
• Provides mentoring regardingsitemonitoringto 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.