RESPONSIBILITIES:

• Responsible for of all aspects of site monitoring activities; Including the conduct of Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Periodic Monitoring Visits (PMVs) and Close-out Visits (COVs) in accordance with ICH/GCP principles. 
• Act as the primary contact/ manager for sites to include, but not limited to the following activities:
• Provide proper training and guidance to site staff on the protocol and all study related materials
• Ensure appropriate safety monitoring, per ICH/GCP principles, are reviewed on an ongoing basis and ensure site has proper oversight of safety reporting requirements
• Acts as the primary contact to assigned sites to ensure there is proper compliance to the protocol, adherence to patient safety, proper IP management and study supply management
• Review sites recruitment and enrollment activities and assist with recruitment planning and solutions as needed. 
• Ensure proper review of the sites Investigational Site File Binder and ensure all plans, communications and logs are maintained and updated appropriately as per ICH GCP and GDP requirements
• Will provide support to all functional groups (as needed) to ensure proper reporting of safety data and proper site compliance to all protocol and protocol related materials
• Will perform site oversight to prevent noncompliance, escalate noncompliance issues and provide guidance/ preventative action plan to prevent future noncompliance as needed

Requirements

QUALIFICATIONS – SKILLS & REQUIREMENTS: 

• Must display proper knowledge of ICH GCP principles and GDP knowledge for compliance with document review/ reporting; ALCOA principles
• Must be able to demonstrate proper organizational skills and have effective communication skills.
• Must be able to work independently managing sites with minimal oversight
• Must be able to demonstrate ability to conduct presentations as necessary
• Must be able to assist and have experience with oversight of sponsor monitoring activities. This will include: Data interpretation, conflict resolution and demonstration of working with different personnel, & provide guidance and solutions for complex issues
• Must have basic knowledge of system tools and web based applications that include, but not limited to: 

Microsoft Outlook, Excel, Word and Powerpoint

CTMS, EDC, eTMF and IWRS systems