• Develop, manage and oversee JHU-wide training and education policy• Serve as a subject matter expert and national leader in education and training• Provide high-level oversight and support of multiple JHU Programs

- Manage the Research Coordinator Program and the ClinicalTrials.gov Program in the ICTR- Represent Johns Hopkins as a National expert in the area of ClinicalTrials.gov and provide guidance and leadership to other research institutions across the US - Continually assess and revise programs including requirements, curriculum, and competencies to meet the needs of Institution and Federal regulations - Ensure the Research Coordinator Program is effective and is able to efficiently train research coordinators. Develop and implementation multi-level evaluation processes to assess the program to determine areas of success and improvement.- Manage a team of employees who will work across the Institution to support research - Accountable for developing contracts for the Clinical Research Coordinator program and ensuring that the budget is on target - Serve as a leader within the Research Community at Johns Hopkins- Develop strategy and implementation of a plan to create effective programs, maximize resources, and enhance the education and training of Johns Hopkins research staff.- Work with ICTR managers and Departments to identify Clinical Research training gaps and develop proposals for ways to fill those gaps.- Manage special projects and initiatives across the Johns Hopkins University

Develop and implement system-wide research improvement initatives throughout the School of MedicineDirect the ClinicalTrials.gov ProgramAssist senior leadership with strategic planning

•Leadership role in developing and implementing division-wide improvement initiatives•Provide leadership and expertise to Principal Investigators and research teams•Develop standardized divisional SOPs and training curriculum for research/lab personnel

•Coordinate all clinical research activity of the Sjogren’s Syndrome Center•Monitor the clinical course and collection of research data and IRB submissions/changes•Develop and maintain clinical forms and a comprehensive patient database

Lead a Study Management Team to deliver highest quality data on-time to clientsTrain and motivate staff to perform at the highest level, troubleshoot and find creative solutions to planned, un-planned, and emergency situationsManage multiple projects assuring protocol, SOP and regulatory compliance

Retained through acquisition to continue previous role within new companyPrimary contact for clients and monitors including scheduling/hosting on-site visits/audits, ensuring data is prepared and responses are accurate and timelyResponsible for internal and external management of all timelines and financials

Promoted as a subject matter expert into Project Manager role Developed, maintained, and reported study budgets and timelinesManage all aspects of projects and communication from pre-study to archival

Team Leader in ensuring GCP, FDA, Protocol, SOP and QA audit complianceHelped open a new 10-bed telemetry unit and conducted a FIM and several other successful Phase 1 studies of marketed and un-marketed pharmaceuticalsTrained staff in all aspects from clinical duties to customer service and software

•Maintained protocol compliance, FDA regulations and GCP guidelines•Planned and hosted all monitor visits and handled all Sponsor/IRB correspondences•Performed Laboratory, ECG, Neuro-cognitive testing and other ratings

•Assisted with life saving procedures, patient transport, vitals, ECGs, serial blood draws•Additional administrative duties (training, recycling, architectural design of new ER) •Worked well with nurses, residents and attending and nominated for employee of the year

•Team leader, technician rep, interviewer, preceptor, trainer, liaison to other departments •Received additional training in orthopedic splinting and involved in improvement plans•Became first “Multiple Function Technician” after working with Management and HR