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.
• 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.

• 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.

• 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.

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.

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.
• Generated site reports in accordance with department timelines.
• Collaborated with the Study Coordinator on-site issues/actions.
• Performed regular review of site-level data.