Functions in a leadership capacity over the clinical function and monitoring team for a project. Has mastered the clinical monitoring process, associated competencies and understands the role of clinical research in drug development. Is an expert on relevant Good Clinical Practice (GCP), ICH, FDA regulatory requirements, and Standard Operating Procedures (SOPs). The Clinical Lead is responsible for quality and on time delivery of all tasks under the clinical function for each project assignment.

Responsibilities

• Responsible for training and mentoring CRAs. Serves as the first point of contact for CRA questions, managing the FAQ and triaging questions to other team members as appropriate
• Leads CRA meetings and communications and ensures proper site oversight and management by CRAs. 
• Oversees site assignments and ensures CRA team is adequately resourced
• Responsible for timely Monitor Visit Report review per required review metrics, standards outlined in Monitoring Plan for each study; communicates report comments/issues to appropriate CRA for report edits. Reviews and confirms monitor time on-site, effectiveness, and efficiency.
• Responsible for identifying suitable clinical trial sites
• Ensures accuracy and completeness of feasibility questionnaires submitted by potential trial sites.
• Review informed consent forms and site-level checklist templates for compliance and accuracy.
• Ensures that issues and action items from monitoring visits are being addressed and closed in a sufficient manner and timeframe. If applicable, addresses with CRA need for site re-education
• Serves as escalation point for critical or non-compliant issues identified during site visits, ensuring appropriate actions are taken.
• Ensures issues and deviations are noted and tracked appropriately in reports and follow-up letters, also performing periodic trending activities 
• Communicates monitoring trends to Study Management (e.g., queries, protocol deviations) and site issues (e.g., enrollment barriers, etc.) which may require further attention
• Performs Quality Control Visits or Interim Monitoring Visits at sites as needed
• Support database build and UAT
• Reviews data management reports to ensure timely query resolution and reviews data for trends as applicable
• Assists in collection and assessment of clinical essential documents
• Coordinate and oversee the site activation process
• Develops source documents and study logs
• Develops monitoring plans, annotated trip reports, and monitoring tools and templates
• Attends study meetings and prepares weekly status reports for the Project Manager
• Collaborates with the Project Manager and other functional leads on activities related to site monitoring, site management and clinical deliverables 
• May participate in Bid Defense Meetings
• Contributes to content and presentation for kick-off meetings, both internal and external, pertaining to clinical management aspects.
• Support database development and UAT