Clinical Research Associate; CRA) III; Hybrid

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.

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(CRAIII) will be responsible for the day-to-day operations associated with the execution of clinical trials and monitoring the clinical trial sitesto ensure they arecomplyingto the applicable study protocol, Standard Operating Procedures (SOPs), CVRxrequirements, Good Clinical Practice  (GCP), and the applicable regulatory requirement(s). The CRAIIIwill work closely withthe

Clinical Study Manager to ensure siteday-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 andserves asthe primary point of contact.
• Assists in preparation of study materials and training of investigators and 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 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…