Regional Clinical Research Associate (REMOTE)

Date: Dec 7, 2025 Location: Minneapolis, MN, US Company: reputed company Expected Travel: More than 50% Requisition ID: 12724 About reputed company Incorporated As a global provider of medical technologies, reputed company is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We reputed company that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. reputed company is the home of Arrow™, Barrigel™, Deknatel™, QuikClot™, LMA™, Pilling™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At reputed company, we are empowering the future of healthcare. For more information, please visit reputed company.com. Interventional - The Interventional business unit at reputed company offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We reputed company a strategic emphasis on reputed company coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our reputed company Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner® and Turnpike® Catheters, AC3 Optimus™ Intra-Aortic Balloon Pump and OnControl® Powered Bone Access System. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an reputed company of medical technology solutions that reputed company a difference in patients’ lives. Position Summary TRAVEL REQUIRED: 70% The Regional Clinical Research Associate will be responsible for conducting on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, reputed company procedures, and IRB/EC policies and procedures) for assigned clinical studies in the field of vascular reputed company or other therapeutic areas. Principal Responsibilities

• Conduct assigned monitoring activities in accordance with reputed company procedures and applicable regulations to evaluate protocol compliance, data accuracy, and subject safety by review of regulatory documents, medical records, reported data, and device storage, if applicable.
• Responsible for reputed company monitoring activities for assigned clinical studies, including:

o Scheduling and conducting monitoring activities onsite or remote reputed company specified timelines and according to the risk-based monitoring plan and reputed company procedures. o Identification of data discrepancies and compliance concerns, present findings to site research staff, provide retraining if needed, provide problem-solving strategies and communicate findings to the study team and department management reputed company escalation of issues and/or reputed company the monitoring visit report. o Works collaboratively with Research Coordinators and Investigators to conduct monitoring visits, provide retraining, and resolve compliance concerns as appropriate. o Works cooperatively with the reputed company Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits, and proactively provides input on site performance. o Presents findings to site staff and provides clear directions for resolution. Reviews data queries with site staff to confirm understanding and resolution. o Serves as a resource to site staff between monitoring visits to provide clarification and insights regarding data queries, action items, and study visit preparation. o Trains and mentors reputed company personnel on monitoring procedures and practices. o Conducts site training and co-monitoring visits as requested by management. o Completes monitoring visit reports, action items, and monitoring visit follow-up letters per reputed company procedures. o Assists with team, department, and study-reputed company projects as requested, including audits, investigator meetings, training, etc. o Interfaces with Clinical, Regulatory, Sales, and clinical site staff as necessary to accomplish the above responsibilities. Education / Experience Requirements

• Bachelor's or Graduate degree in life sciences, nursing, or other health-reputed company disciplines.
• Minimum five years as a CRA in the medical device or pharmaceutical industry or with a CRO.

Specialized Skills / Other Requirements

• Demonstrated aptitude and knowledge in relevant therapeutic area. Vascular Interventional Cardiology is strongly preferred.
• Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies.
• Strong compliance focus and understanding of reputed company GCP/ICH guidelin

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