Clinical Research Project Coordinator V

Medtronic•Mounds View, MN

3d•Onsite

About The Position

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.

Requirements

High school diploma or equivalent
Minimum 10 years experience providing operational and project coordination support.

Nice To Haves

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.

Responsibilities

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.
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.
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.