Bettie Thomas Email & Phone Number

8045 Arco Corporate Drive, Suite 130, Raleigh, Nc 27617

Research Triangle Park

● Act as a liaison between study site, investigators, CRO and Sponsor.● Develop and maintain study documents as per regulatory and monitoring plans.● Submit regulatory documents to Central/Local IRB/EC on behalf of Sponsor and/or clinical sites as appropriate. Received from Central/Local IRB/EC applicable correspondence and assures these documents are maintained in the Study Master File.● Obtain study specific documentation from sites as required per regulatory plan in a timely manner.● Provide essential documents to sites, instruct, and perform quality assurance to ensure documents are completed accurately and within required project timeline.● Submit Initial studies, Protocol (amendments) to the IRB/IEC.● Provide updates to the tracking system (CTMS) with comments and milestone dates.● Negotiate with site changes to ICF before providing to study team for approval.● Provide site status to Clinical Team and alert the team for any site that is at risk for missing the agreed-upon timeline.

● Accountable for study data quality and integrity for the entire duration of the study – from design through delivery to reporting.● Defined data capture strategy in line with protocol and reporting needs with a focus on eliminating unnecessary data collection.● Ensured all systems were set up to implement the study plan and track the progress of the study.● Accountable for the development and release of the data capture tools by engaging the study teams in the development of the data capture tools. ● Performed in-stream data review to detect data trends and then deliver a data quality plan for action resulting from in-stream data review.● Authored Study Sponsor Monitor Plan, Data Quality Study Plan, Data Management Communication Plan and Vendor Transfer Specification Plan. ● Provided training to site monitors on study specific data capture tools and data quality processes.● Assisted in the development and provided comprehensive review of CRF Completion Guidelines (CCGs) and Data Validation Specification.

● Managed study execution, tracking, and management of study delivery from start to completion.● Developed and maintained global study budget, ensuring cost-effectiveness and addressing and highlighting issues as appropriate.● Participated in investigator and team meetings.● Accountable for site and monitor training in all operational aspects of the study.● Ensured study-related communications and resolutions or escalations of operational issues were highlighted and resolved.● Monitored study timelines, patient recruitment, and retention to ensure a successful outcome of the project.

● Managed and coordinated workflow tasks and a staff of 10 to 14 Clinical Research Coordinators to accomplish deliverables.● Identified staff resource needs across Respiratory programs by partnering with Support Resource Management and ensured that all studies were resourced.● Conducted training to Clinical Support Specialists on following best practices and standard processes as well as mentored entry level or new staff.● Enhanced the partnership between Clinical Support Staff and Scientist across therapeutic areas by providing verbal or written reports on startup activities, IRB review, problem sites, budget challenges etc. during study progression.

Rtp

● Led 10 Clinical Support Specialists providing operational support for delivery of assigned studies on time and within budget.● Resolved routine and complex requests, escalated complex requests as appropriate and recognized underlying issues.● Conducted study start-up activities including the collection of regulatory documents and ensuring the accuracy of documents.● Managed the startup, maintenance and closeout process on assigned projects.● Ensured accuracy and integrity of study data within study systems through independent and proactive pulling data from tracking system.● Created, updated, and implemented Standard Operating Procedures (SOP) and guidelines to ensure standardization and adherence to best practices for collecting and reviewing essential documents.● Performed quality file audits for vendors (CRO), specific to investigator files, trial master file (TMF), country, and central files for compliance during the conduct and close-out of the clinical trial in preparation for NDA submissions.● Interviewed, trained, and mentored new Clinical Support Associate staff in meeting study objectives while following established procedures and SOPs.

Rtp

Selected for Secondment and co-monitored with Sr. Clinical Research Associates● Provided support on high priority Oncology, Cardiovascular and Respiratory projects ● Conducted site visits in accordance to the study-specific Monitoring Plan, including:o Followed-up on appropriate site-related questionso Reviewed recruitment plan and enrollment updateso Addressed protocol questionso Verified site staff assignmentso Assessed drug/study supply statuso Ensured required documentation was obtained● Generated site reports in accordance with department timelines.● Collaborated with the Study Coordinator on-site issues/actions.● Performed regular review of site-level data.● Trained site team members on study specific tasks.● Collaborated with site personnel resulting in 100% of required paperwork submitted on time and data issues resolved timely.