Clinical Research Associate (CRA) III

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 with travel to various sites across the southern US.
  
  
• Please note that if our ideal candidates reside near our headquarters in Brooklyn Park, MN we ask that you be open to occasional on-site visits to our HQ for meetings, as required.
  
  
• Travel: Please note that this position requires travel up to 50% as needed to support monitoring in sites across the US.
  
  

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.

Collects and tracks required regulatory documents from various Clinical Centers as assigned.

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

Evaluates site performance through analysis of enrollment trends, data quality metrics, protocol deviations, product accountability, and patient safety parameters.

Supports sites in AE/SAE identification, documentation, and reporting.

Verifies timely submission of required safety documentation, device complaint forms, and follow-up queries. 

Drives proactive risk identification at the site level and support the execution of risk-mitigation plans.

Sources and 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.

Works closely with Clinical Project Managers, Data Management, Safety, Regulatory, Quality, and Training to ensure end-to-end study execution.

Provides operational input on protocol development, CRFs, risk assessments (RACT), monitoring plans, investigational brochures, and essential document requirements.

Collaborates in Trial Master File (TMF) on quality checks to ensure site-level documentation is complete, audit-ready, and compliant.

Contributes to process improvement initiatives, QMS updates, and clinical operations optimization.

Assist management in metrics reporting, monitoring dashboards, and early risk detection through data analytics.

Participates 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 other 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

WORKING CONDITIONS AND REQUIRED PHYSICAL EFFORT

• 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