MERIT CRO

Project Manager

• Assist the Project Management Division with coordination and conduct of project management activities under direct supervision
• Create and distribute study-related documents
• Support management of clinical trial data in the EXCELSIOR™ cloud application environment
• Perform data uploads and quality control functions
• Record and distribute meeting minutes
• Maintain controlled documents, including Master Project Files
• Provide support to clinical sites, reading centers, and clients according to company and study-specific procedures and GCP
• Organize and coordinate controlled documents and office tasks
• Assist with study management and development, proofreading, creation, duplication, and dissemination of project and regulatory documents
• Respond to quality review audits and monitor work quality and completeness
• Support study activities from start-up through closeout
• Organize and prioritize assignments and anticipate problem areas
• Initiate Master Project Files and maintain project documents
• Generate and email eligibility notifications
• Attend internal and sponsor project meetings via teleconference or face-to-face
• Coordinate with Shipping and Receiving to confirm shipment and receipt of study materials
• Review EXCELSIOR™ study-specific configuration
• Manage and review site surveys and update EXCELSIOR™ for site registration
• Provide guidance and training to sponsors, CROs, clinical sites, and graders on EXCELSIOR™ functionality and technical support
• Perform image check-in and quality control
• Issue and review data query responses
• Review, categorize, and respond to helpdesk customer support and complaint tickets
• Perform and document periodic reviews of inactive EXCELSIOR™ users
• Comply with company policies and SOPs
• Promote quality, continuous improvement, safety, and customer satisfaction

Project Coordinator I