Clinical Research Project Coordinator V

We anticipate the application window for this opening will close on - 3 Aug 2026 Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. # **A Day in the Life** At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This position will be based in Mounds View, MN. The **Clinical Research Project Coordinator V** provides advanced operational and project coordination support for global clinical research studies and research programs. This role serves as a key member of the Clinical Operations team, ensuring efficient study execution through coordination of study documentation, systems, training, communications, and operational activities. The Project Coordinator V works independently on complex assignments, supports multiple studies or programs simultaneously, and collaborates with cross-functional stakeholders to ensure compliance, quality, and timely delivery of clinical research objectives. **Key Responsibilities** **Clinical Study Operations** - Coordinate and support global clinical research studies from study start-up through closeout. - Maintain study documentation and essential files in accordance with applicable regulations, SOPs, and quality standards. - Manage study data entry, filing, document review, and records management activities. - Support development, distribution, tracking, and reconciliation of study materials and investigator communications. **Systems and Process Support** - Lead study system setup, user access requests, troubleshooting, and ongoing support for clinical systems. - Ensure accurate maintenance of study information in applicable electronic systems and databases. - Identify opportunities for process improvement and support implementation of operational efficiencies. **Training and Compliance** - Coordinate study-related training assignments and completion tracking for internal and external stakeholders. - Assist with preparation for audits and inspections by ensuring documentation readiness and compliance. - Support adherence to Good Documentation Practice (GDP), company policies, and applicable regulatory requirements. **Must Have; Minimum Requirements** *To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.* - High school diploma or equivalent - Minimum 10 years experience providing operational and project coordination support. **Nice To Have** - Experience supporting multi-site or global clinical studies. - Experience with electronic trial master file (eTMF), CTMS, EDC, and document management systems (e.g., Medidata Rave, Veeva Vault, Cornerstone OnDemand). - Strong understanding of GDP and clinical trial processes.. - Proficiency with Microsoft Office Suite. - Ability to manage multiple priorities in a fast-paced global environment. - Working knowledge of GCP, ICH guidelines, ISO requirements, and FDA regulations. - Project management certification or equivalent experience. - Demonstrated ability to lead process improvement initiatives. For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees a…