Shanita Crawford

• Provide clinical support and expertise on ongoing trials from start up to close out • Managed study milestones, proactively addressing risks with cross-functional teams • Oversaw budget forecasting and financial accountability for global clinical trials.

• Managed and oversaw the study’s day-to-day clinical operations of CRO including management of patient recruiting, project management, vendor management, ancillary supplies, regional management, eTMF readiness, quality activities, biostats and data management • Led weekly meetings to discuss the status of study milestones and status. • Worked with team to proactively address any risks with the cross functional departments and create mitigations • Created ad hoc reports and presentations to inform the team where we are with the study, areas that need attention and the upcoming study milestones. • Routinely interacted with key internal and external stakeholders communicating project status and escalated issues • Responsible for study budget and forecasting. Accountable for study level time and quality deliverables with a global aspect • Set up eTMF structure by reviewing the eTMF Index with functional leads to ensure it is reflective all applicable documents • Reviewed metric report outputs with Study Teams on a recurring basis to address missing, duplicate, or incorrect documents • Performed ongoing review of site, study, and country documentation in the eTMF to ensure audit readiness

• Managed and oversaw the study’s day-to-day clinical operations of CRO including management of patient recruiting, project management, vendor management, ancillary supplies, regional management, eTMF readiness, quality activities, biostats and data management • Led weekly meetings to discuss the status of study milestones and status. Worked with team to proactively address any risks with the cross functional departments and create mitigations • Created ad hoc reports and presentations to inform the team where we are with the study, areas that need attention and the upcoming milestones. Routinely interacted with key internal and external stakeholders communicating project status and escalated issues. • Worked with QA to create CAPAs for CRO and discussed the mitigation and prevention plans to ensure situations did not occur again • Responsible for overall study budget and forecasting. Accountable for operational study level time and quality deliverables with a global aspect. • Responsible for preparing Global Country Budget Templates and executing a variety of agreements and amendments (e.g. Confidentiality Agreements (CDA), Clinical Trial Agreements (CTA), Budgets, and Letters of Indemnification (LOI))

• Managed and oversaw the study’s day-to-day clinical operations of outsourced and insourced studies including management of patient recruiting, project management, vendor management, ancillary supplies, regional management, eTMF readiness, quality activities, biostats and data management • Created master regulatory templates and distributed start up packets and materials to sites for local and central IRB/IEC submissions. • Collected, reviewed, and approved essential documents and ICFs pre and post IRB submission. • Served as primary point of contact for Ethics Committees, Ministry of Health, Institutional review boards and other applicable global regulatory authorities to resolve protocol questions • Provided oversight of CRO monitoring activities including review of metrics representing quality and deliverables • Reconciled eCRFs with CRA activities and provide feedback to CRAs on actions needed with sites • Co-monitored sites to ensure procedures were followed and to establish a relationship with the site • Set up lab specs based on protocol. Managed lab inventory to ensure sites supplies were on site based on the scheduled patient visit • Created reports to track biosamples being shipped to Vaxart and reconciled manifesto with samples received. Followed up with the sites for any missing, delayed, or incorrect samples and to resolve any lab queries • Reviewed documents for completeness before uploading them into eTMF and completed the meta data for submission for insourced studies • Reviewed Veeva Vault metric report outputs with CRO on a recurring basis to address missing, duplicate, or incorrect documents for outsourced studies • Set up external Data Monitoring Committee (DMC) content, structure and contracts based on protocol schedule • Prepare DMC meetings and disseminated the decisions to sites and CRO • Responsible and accountable for SAP/TLF template finalization for DMC and SMCs. • Created Protocols, Investigator Brochures, and Amendments.

• Managed and oversaw the study’s day-to-day clinical operations of outsourced and insourced studies including management of patient recruiting, project management, vendor management, ancillary supplies, regional management, eTMF readiness, quality activities, biostats and data management • Achieved all study milestones (FPI, LPI, LPO) ahead of schedule; acknowledged by Merck’s SVP, Head of Global Clinical Operations for Leading by Example award in 2018 and received multiple awards from Execupharm based on performance and mitigation • Managed Investigator meetings that led to 100% site attendance at multiple international meetings • Led first adjuvant study with Merck and set up processes and template according to our protocol procedures • Set up study parameters for IVRS, Patient Reimbursement and Imaging vendors/ Set up eCOA for tablet, mobile and paper distribution • Reviewed queries issued to sites to assist with resolution • Set up eConsent with Vendor for patient use • Led weekly meetings to proactively address any risks with the cross functional departments and create mitigations • Met with Investigators and staff during congresses and road trips to discuss enrollment challenges and potential solutions • Implemented regional patient recruitment and boosting efforts that resulted in enrollment ending four months ahead of schedule despite multiple direct competing trials occurring at the same time • Set up Risk Based Monitoring criteria and parameters for low, medium, and high risks • Brought on rescue sites and countries in expedited start up timelines to replace non performing sites • Responsible for overall study and site budgets; ensure change orders and site requests are within scope

• Distributed, collected, reviewed, and approved essential documents and ICFs pre and post IRB submission. Prepared greenlight packages for assigned clinical sites. Forecast and tracked metrics and progress of site start-up for weekly meeting updates • Served as site’s primary point of contact for sites • Maintained a tracking system for the progress of clinical trial start-up and site activation, generating regular status update reports • Responsible for preparing, negotiating, tracking, and executing Confidentiality Agreements (CDA), Clinical Trial Agreements (CTA) and Budgets • Manage, process, and tracked site invoices and payments • Reviewed data from EDC to validate site invoices and release site payments. • Develop and distributed consolidated monthly payments reports detailing the status of paid/unpaid invoices • Remotely reviewed EDC and issued site queries, worked with sites to close queries and resolved issues before database lock • Performed GCP audit on TMF at country, site, and study level. Performed site file review and provided findings to CRAs to address with the sites. Served as a backup contact for collection of missing items if CRA was traveling • Provided oversight of CRO monitoring activities including review of metrics representing quality and deliverables as well as direct oversight of clinical monitor activities. (e.g., trip report review, co-monitoring) • Attended and organized Investigator Meetings; prepare protocol slides, organized department slides and handout materials

• Responsible for preparing, negotiating, tracking, and execution of CDA and CTA agreements and amendments. Managed all required contractual agreements, with investigator sites. Negotiated contract and budget modifications, quality control, tracking and routing for execution. Worked with Legal to finalize contract for any non-approved language or terms. • Prepared contract approval timelines with investigators and leads efforts to obtain contract approval to meet study deliverables • Sent start up packets and materials to sites for local and central IRB submission. Collect, review, and approved essential documents and ICFs pre and post IRB submission. Prepared greenlight packages for assigned clinical sites • Forecast and tracked metrics and progress of site start-up for weekly meeting updates. Ensured site’s essential documents are filed in TMF

• Conceptualized and implemented structure and processes for a Study Start Up Department • Forecast, prioritize and directed the Study Start up staff to achieve on-time quality sponsor deliverables, contractual project requirements, utilization goals and profitable results. This resulted in 92% of all projects having multiple sites up before the contractual FPI date. • Developed start up plans and incorporate such plans within a standard study guideline adhering to Good Clinical Practices (GCP), FDA regulations and ICH guidelines for clinical research to ensure compliance • Developed budgets for the study start up component of proposals, presents at bid defense meetings • Managed third party vendors • Managed Document Management System and paper Trial Master Files for study document collection. • Oversaw site file audits, implemented processes for TMF structure and set up • Worked with each Project Team to set up TMF structure • Review and approved reports and manuscripts, as necessary

•Provided study and process oversight to my assigned staff on awarded projects of $150 million and above •Conducted the hybrid study including writing the feasibility report, gaining significant experience and exposure with global feasibility trials and reporting •Provided site selection of top tier investigator sites; attending conference to speak with physicians in specific indications to increase interested and experienced investigators in the database, as well as through recruitment for active trials • Created bid proposals and text in order to support Quintiles opportunity to win new and repeat business. • Provided financial process oversight; identify scope of work, communicating with internal and external clients and line management as appropriate

• Built project specific CTMS database for Clinical trials per protocol requirements for Site Information, Essential Documents, Deviation/ Violation, Budget/ Payment, CRF and Subject Visit Tracking reports for studies in start up, interim and close out stages. • Disseminated information on company’s clinical computer systems in Proposal and Kickoff meetings. • Supervised and assisted with Phase II -IV Clinical Operation project setups, unique project requirements and user report generation. • Facilitated training sessions for RTP and Wilmington areas and created training tools that prepared new and existing employees to perform at an optimum level in their job function.