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.

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 sitesto 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 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.
• 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).
• Assis…