Charles Edgar Clavecilla Email and Phone Number

• Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents,• Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.• Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.• Maintains timely and effective communication among team members and site staff. • Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.• Provide administrative support to Project Leads and functional leads.• Ensure all study documents are archived based on the appropriate guidelines and policy.• Provide support for quality assurance activities, including preparation for audits and internal review,

- Performs activities in compliance with applicable Corporate and Clinical Operations Policies,Standard Operating Procedures (SOPs), Work Instructions (WIs), and GCP & ICH Guidelines.- Maintains timely and effective communication with study team regarding assigned task &deliverables.- Performs assigned activities that support study maintenance such as but not limited to: oMaintenance of Trial Master File (TMF), perform TMF document process activities applicable forPTSC.o Maintenance of Syneos Health clinical applications and core systems.o Study support task delegated to PTSC within applicable scope.- Ensures that internal/external customer expectations are achieved.- Identifies best practices and participates in process improvement.- Maintains compliance with departmental quality, performance, and utilization targets.- Performs other work-related duties as assigned.

Technical Support Analyst with total of 6 years of experience in a clinical research company. 5 years as a Technical Customer Support Analyst and 1 year as a Sr. Production Data Input. Highly trainable, consistent achiever and with excellent work etiquette for 6 years. Always motivates and provides positive outlook to the team.