Clinical Research

• Execute day-to-day operations associated with clinical trials
• Monitor clinical trial sites for compliance with study protocols, SOPs, CVRx requirements, GCP, and applicable regulations
• Work closely with the Clinical Study Manager to meet project deliverables
• Develop and maintain working relationships with study sites as the primary point of contact
• Assist with preparation of study materials and training of investigators and site staff
• Support site IRB or ethics committee submissions
• Collect and track required regulatory documents from Clinical Centers
• Coordinate and conduct monitoring at participating centers
• Prepare and submit monitoring reports
• Evaluate site performance using enrollment trends, data quality metrics, protocol deviations, product accountability, and patient safety parameters
• Support AE/SAE identification, documentation, and reporting
• Verify safety documentation, device complaint forms, and follow-up queries
• Identify site-level risks and support risk-mitigation plans
• Source-verify clinical data and oversee data correction
• Maintain Clinical Study files and Trial Master File documentation
• Manage device accountability at sites, when applicable
• Process payments to sites, vendors, and consultants
• Review center activation documentation
• Collaborate with Clinical Project Management, Data Management, Safety, Regulatory, Quality, and Training
• Provide operational input on protocols, CRFs, risk assessments, monitoring plans, investigational brochures, and essential documents
• Contribute to TMF quality checks, process improvements, QMS updates, and clinical operations optimization
• Assist with metrics reporting, monitoring dashboards, and early risk detection through data analytics
• Participate in vendor oversight
• Train and mentor Clinical Research Associates and internal team members
• Interface with Regulatory Affairs, Quality Assurance, Research & Development, U.S. Market Development, Commercial Development, and Clinical Research Organizations
• Complete special projects and assigned job-related duties

Clinical Research Associate III

• Manage research activities at sites participating in Worldwide’s clinical research projects
• Identify potential sites to participate in research
• Perform study start-up activities, including collecting regulatory documents from sites
• Support negotiation of contracts and budgets
• Train sites to collect data properly and report potential safety-related events
• Manage site activities during study maintenance
• Close down research activities at sites once the study has concluded
• Conduct study initiation visits (SIVs)
• Ensure compliance with informed-consent procedures, safety-event reporting, and applicable regulatory requirements

Clinical Research jobs in Minnesota

Clinical Research Associate III

Senior Clinical Research Associate – Oncology