Clinical Site Monitoring Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervises the monitoring effectiveness

• Executes various oversight encounters and activities as necessary, including site risk analysis and site contacts

• Consistently completes Sponsor Oversight Visit reports on schedule and with high quality

• Employs a risk-based strategy to assess critical quality items at both the site and study levels

• Develops Study Specific Oversight Plans (SSOPs) for relevant trials within scope

• Identifies and implements alternative and innovative solutions to address problems affecting clinical site delivery and quality

• Aids in preparation for and management of inspections

• Cultivates relationships with investigators and site personnel in the region; serves as a resource for identifying potential sites for new studies

⛳️ Requirements

• Extensive direct CRA/monitoring experience obtained with a CRO or pharmaceutical company involved in multinational clinical studies

• Direct involvement in managing and overseeing trends in the Risk Based Quality Management model/issue management

• Experience as a Lead CRA is essential

• Familiarity with all phases of clinical research (Phase I-III)

• Proficient in MS Office Suite (Excel, Word, and PowerPoint); capable of learning both internal and external computer systems

• Proficient in written and spoken English is mandatory

🏝️ Benefits

• Health insurance

• Opportunities for professional development