As a Senior CRA, in addition to the normal requirements of the position, I have alsoaccomplished the following:• Been selected to directly interface with the sponsor• Been selected to host the CFO and CIO for site visit training• Been the point person for new CRA on-boarding training• Monitored outside of the United States, with the necessity of incorporating internationalclinical regulations• Created, run, and analyzed reports on CRA on-site metrics, clinical data, and regulatorydocument tracking• Managed an ad-hoc team of CRAs for additional visits which led to database lock 14 daysahead of schedule• Created work flows for multiple clinical processes• Hosted and trained visiting CRAs from Japan• Reviewed trip reports

• Trained other staff members on site visits, monitoring, Microsoft Office, and database usage• Recognized within the corporation as a Microsoft Word Subject Matter Expert• Reviewed and edited study documents, including protocols, study manuals, and monitoring plans• Monitored clinical trials to ensure sponsor and investigator obligations were being met and activities were compliant with applicable local regulatory requirements and ICH guidelines• Visited sites to assess the qualification of potential investigative sites, initiated studies, instructed site personnel on the proper conduct of studies, reviewed data and ensured accuracy of data collected and to terminate studies• Prepared appropriate documented communication to site and completed trip report documentation• Provided regular clinical status information to team members and project management• Performed billable work in accordance with policies, procedures, and Standard Operating Procedures (SOPs)• Worked closely with other team members to ensure timely resolution of project and/or clinical issues• Performed investigative site file reconciliation; requested any new or updated site-related essential and non-essential documents and reviewed them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements

• Reviewed budgets and contracts for multiple studies• Created proposals and templates for executive-level bid defenses• Created business practice templates and individual business practices• Taught myself Microsoft Access and utilized it to increase efficiency by querying databases to discover incongruities. These then became a key part of the study data cleaning process• Trained other staff members on site visits, monitoring, Microsoft Office, and database usage• Independently created a Society of Clinical Research Associates certification study group and created all materials for weekly trainings. All members of the study group passed the certification with high scores.• Reviewed Clinical Study Reports for multiple studies and corrected inconsistencies which the sponsors specifically noted as critical.• Recognized within the corporation as a Microsoft Word Subject Matter Expert• Performed over 100 study monitoring visits• Independently applied for and was accepted into UNC School of Public Health Leadership Program. Currently in the second semester of the program.• Reviewed and edited study documents, including protocols, study manuals, and monitoring plans• Monitored clinical trials to ensure sponsor and investigator obligations were being met and activities were compliant with applicable local regulatory requirements and ICH guidelines

• Monitored clinical trials to ensure sponsor and investigator obligations were being met and activities were compliant with applicable local regulatory requirements and ICH guidelines o Visited sites to assess the qualification of potential investigative sites, initiated studies, instructed site personnel on the proper conduct of studies, reviewed data and ensured accuracy of data collected and to terminate studies o Prepared appropriate documented communication to site and completed trip report documentationo Provided regular clinical status information to team members and project management o Performed billable work in accordance with policies, procedures, and Standard Operating Procedures (SOPs)o Worked closely with other team members to ensure timely resolution of project and/or clinical issues • Performed investigative site file reconciliation; requested any new or updated site-related essential and non-essential documents and reviewed them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs, and sponsor requirements • Performed source document verification, reviewed drug accountability and safety and documents deviations to protocol and regulations at investigative sites • Reviewed Serious Adverse Event (SAE) reporting for compliance with regulations/specifications • Responded to requests from investigative sites/ensured queries are resolved in a timely fashion • Interacted with other functional areas to resolve site issues and facilitate project timelines • Mentored junior level CRAs, reviewed trip reports and served as a resource for new employees • Scheduled and reviewed team member tasks, reviewed generated documents, provided leadership in the delivery of services to clients, and ensured that team fulfilled their responsibilities in accordance with policies, procedures, and SOPs

• Executed and maintained communication and documentation for clinical studies in compliance with applicable local regulatory requirements and ICH guidelines. o Maintained study communication tools including web-based study applicationso Coordinated shipping and tracking with all phases of the clinical studieso Provided regular clinical status information to team members and project management and drafts study documentso Performed billable work in accordance with policies, procedures, and Standard Operating Procedures o Worked closely with other team members to ensure timely resolution of project and/or clinical issues and obtained direction from more senior clinical operations staff. • Performed regulatory file reconciliation and maintained central files; requested any new or updated essential and non-essential documents and reviewed them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements• Performed limited monitoring responsibilities including co-monitoring sites, co-preparing trip reports, in-house monitoring of data, query writing and communicating with/assisting site(s)

• Was responsible for daily update and accuracy of databases • Provided support for Phase-IV study including ensuring budgetary compliance through increased efficiency. • Was the organizational point of contact for doctors, pharmacies, patients, and clinical research associates. • Worked closely with clinical team to ensure project compliance and standardization.