HIGHLIGHTS

• Enthusiastic, proactive research professional with extensive history of utilizing quantitative and qualitative research methodologies to conduct: health services, epidemiologic, health economics and outcomes research, as well as program evaluations and clinical trials. Excel in collaborating with government agencies, payer organizations, institutions of higher education, and healthcare organizations in domestic and international environments.
• Recognized as conscientious, quality-driven, and improvement-focused thought leader with clinical and research expertise and sharp critical thinking skills. Known for commitment to meeting and exceeding internal/external customer expectations, plus proven ability to adapt project priorities in rapidly changing environments.
• Inclusive leader skilled in mentoring, developing, and empowering students, junior staff, and teams. Foster creativity and innovation, while providing team members with opportunities to expand skill sets and develop their careers.

CORE COMPETENCIES

• Research Project Design Management Program Evaluation Outcomes Research Grant Writing
• Clinical Trials Management Monitoring Data Collection Tool Design, Testing Administration
• Data Analysis Plan Creation Execution Database Development Management Budgeting
• Decision Analytic Modeling Writing for Publication and Presentation Data Visualization
• IRB Application Reporting Patient Recruitment Retention Planning
• Mentoring, Teaching, Training wTeam Building Leadership

PROFESSIONAL EXPERIENCE

Confidential

• Senior Research Project Manager, Data Manager/Analyst As the appointed Research Coordinator at Confidential Research Institute, I was assigned the task of collaborating with colleagues at the Confidential to develop a two-phase international research grant application.
• In this role, I identified the necessary tasks to prepare the competitive grant application, assigned and monitored performance in completing those tasks and submitting the application on time. Once awarded, I also made resource decisions for the planning, implementation, and management of the project. The successful application was funded by the National Institutes of Health to create an international research center in Confidential, assemble and train a research team to collaborate with their Confidential counterparts at the aforementioned universities, and conduct a randomized clinical trial of Methotrexate and Classical Ayurvedic Medicine in the Confidential. In year 3 of the project, I managed the successful transition of the primary study location from Confidential, and then to the AVT Institute for Advanced Research for the remaining years of project. During this two-phase project, I have performed the following duties:
• Assessed foreign institution's IT research infrastructure, recommended, and advocated for necessary upgrades, and led IT and data teams based in Confidential
• Collaborated in the design, implementation, and remote daily management of the protocol for the: Double-blind, Randomized, Double-dummy, Placebo Controlled Trial of Confidential or the Combination in the Treatment of Confidential
• Assisted in preparation of IRB application, informed consent document, and provided monitoring and reporting
• Developed job descriptions and provided input regarding hiring and dismissal decisions
• Delivered training in Good Clinical Practices for Clinical Trials GCP and Good Clinical Data Management Practices GCDMP
• Created study Case Report Forms CRFs to gather patient based outcomes as well as medication and laboratory data, research study documents, and Standard Operating Procedures SOPs s for data collection and cleaning
• Delivered training in, and monitoring of, the recruitment, screening, interviewing, and retention of research participants
• Established and conducted data quality assurance QA activities including query resolution and reporting services
• Created clinical trial site monitoring documents, provided assistance with site monitoring, and managed source and regulatory documents
• Designed, implemented, and managed study databases, data dictionaries, data analysis sets, and analysis requests
• Prepared and executed statistical analysis plan, as well as analysis of safety data for regulatory reports and
• Conducted literature searches and participated in report, presentation, and manuscript preparation.

Senior Research Program Manager

In this contract funded position, I managed several large clinical and health outcomes studies and epidemiological research projects, including: An Analysis of the Relationship between Myocardial Infarction, HIV, and Antiretroviral Therapy Health Care Utilization and Clinical Outcomes Among HIV Infected Adults HIV Retention in Care HIV and Malignancy Trends the Center for AIDS Research Clinical Network of Integrated Clinical Systems Hopkins site the North American AIDS Cohort Collaboration on Research and Design of the International Epidemiological Databases to Evaluate AIDS Hopkins site and the HIV Research Network Hopkins site

Specific tasks for which I was responsible include:

• Designing, implementing, and leading clinical, health services, patient outcomes, and epidemiological research projects and program efforts
• Developing and managing multidimensional databases containing claims, pharmacy, and outcomes data, as well as analyzing and reporting on the data
• Assigning, training, overseeing, and evaluating tasks performed by on- and off-site clinical and research project team members
• Developing data collection tools such as surveys, chart abstraction forms, CRF and associated protocols, project plans, data management and analysis plans, informed consent documents, and participating in the preparation of IRB applications
• Providing data management of several complex, longitudinal studies with oversight of IT staff involved in the projects
• Creating, or participating in the development of, recruitment and retention plans, including training in and monitoring of recruitment process
• Attending and contributing to Investigator meetings, site visits, and clinical conferences
• Designing and implementing systems for monitoring, reporting, and quality assurance activities for on- and off-site health, clinical, outcomes, and epidemiological studies
• Ensuring program quality, research fidelity, and adherence to goals and timelines
• Conducting statistical analyses of pharmacy, cost, and clinical and health outcomes data, and preparing reports
• Participating in the development of ne and continuation project grant applications
• Working closely with PIs to ensure adherence to regulatory requirements
• Directing data managers in developing and making database enhancements, queries, and reports
• Developing budgets with PI and CoPIs in addition to monitoring budget expenditures and
• Making strategic recommendations/decisions to meet project goals.

Confidential

Senior Consultant

• Managed the following health and economics outcome projects from design through completion for federal, state, and local governments, as well as payer, private and nonprofit organizations: Medicare Payment Advisory Commission MedPAC Health Care Quality and Payment Analysis Operational Research for Home Healthcare and Hospice State Licensing Agencies, Professional Associations, and Providers Negative Pressure Wound Therapy Quality of Care and Financial Indicators for Hospice and Home Health Agencies and Wound Care Data Repository Development and Research. Specific responsibilities I executed in the management of these projects include:
• Retrospective cross sectional and longitudinal analysis of large federal, state, and local government, and provider claims, pharmacy, and health and clinical outcomes datasets >2 million CMS records
• Developing and managing of grant applications, budgets, industry contracts, subcontracts, and project plans and task lists
• Analyzing data in various formats and preparing reports of healthcare finance, utilization, outcomes, and policy changes
• Conducting quality of care, process improvement, and cost-effectiveness studies
• Developing quality of care indices and performing psychometric testing
• Assisting state home health and hospice associations in quality improvement project planning, data collection and submission, report interpretation, implementation, and monitoring
• Preparing IRB applications, exemption requests, and progress reports
• Directing and coordinating diverse, cross departmental, and inter-organizational project teams ranging in size from 3 to 12 members
• Database development and management, including QA activities, query resolutions, and reporting services
• Leading work group in the development and implementation of project management, data management, and QA SOPs
• Creating and testing data collection tools, training staff to perform data collection and cleaning, and monitoring adherence to data collection protocols and data quality
• Patient recruitment plan development and training for multiple study sites
• Developing and executing statistical analysis plans, and training staff in statistical methods and software and
• Authoring literature reviews, reports, manuscripts, and preparing and delivering presentations.

Data Manager/Analyst

• Coordinated the following clinical research studies and provided database development/management, and statistical analysis for the Clinical Trials of: Echinacea for Upper Respiratory Confidential and Alternative Medicine End of Life Therapy Silymarin for Chronic Hepatitis C Allium sativum for Hyperlipidemia Induced by HAART in HIV-Positive Individuals and Telehealth Delivery of Weight Loss Program for Diabetics. Responsible for database development/management and statistical analysis for two laboratory projects: Cytotoxic Effect of Oyster Mushroom Pleurotus ostreatus on Human Androgen-Independent Prostate Cancer PC-3 Cells, and Quality Assurance of Lactobacillus-containing Dietary Supplements Commercially Available inConfidential. Co-authored two National Institutes of Health Developmental Center grant applications: Planning Grant for Development of International Center for CAM Research on Ayurvedic Medicine, and the
• Developmental Center for Research on CAM to study Trametes Versicolor-Induced Immunopotentation. My primary duties as the Research Coordinator and Data Manager/Analyst for these projects and programs were:
• Daily project and operations management
• Designing and utilizing data collection tools e.g., surveys, CRFs and chart abstraction forms-electronic and paper-based , usability tests, and focus group scripts
• Preparing grant application and budgets
• Creating data analysis plans, code books, analytical datasets, and conducting statistical analyses
• Performing data documentation, data requests, query resolution, and report preparation
• Managing data cleansing and data quality
• Authoring and editing annual reports and manuscripts, and conducting literature reviews
• Guest lecturing on research methods and clinical trials for undergraduate and graduate level courses
• Developing SOPs, subject recruitment plans, and IRB applications and reports
• Initiating, monitoring, and conducting study site start-up and close-out visits
• Compiling and maintaining regulatory files and binders, source documents, and drug accountability records
• Hiring, supervising, and training graduate student assistants, research interviewers, and support staff
• Mentoring pre-post-doctoral fellows in grant writing, IRB application development and reporting, budgeting, study design and methodology, and data management/analysis
• Developing recruitment and retention plans, as well as providing training and monitoring
• Designing and administering structured and unstructured research participant interviews, and surveys
• Conducting research participant clinical visits from screening through study completion, including human specimen/sample collection, monitoring medical status, and administering questionnaires and assessments according to the study protocol
• Co-scripting, directing, recording, and co-editing intervention educational videos
• Administered Faculty Seed Grant and External Research Programs and
• Served on Research Steering Committee and IRB Team B.

Independent Contractor - Research Coordinator

• Designed and conducted evaluation of Biotechnology and Information Technology Worker Retraining program costs and effectiveness as part of a Department of Labor program instituted by the PSC. In this role, I independently:
• Conducted extensive literature revie and identified best research methodology to conduct multi-faceted study measuring program effectiveness and costs
• Designed study protocol and ensured regulatory compliance and QA activities
• Prepared IRB application, informed consent document, study recruitment materials, and reports
• Created survey data collection tools, focus group scripts, and study databases
• Developed and managed project task list, databases, analysis sets, and documentation
• Conducted participant screening, obtained informed consent, and enrolled eligible subjects
• Trained study team in data collection, protocol adherence, protection of research participants and informed consent process
• Led data collection activities, data entry, query resolution, and data cleaning
• Performed statistical analysis and prepared reports and presentations and
• Reported findings and recommendations to stakeholders.

Confidential

Independent Contractor

• Prior to receiving a National Institutes of Health NIH Small Business Innovative Research SBIR award, Screen, Inc., contracted with me to provide study and grant application development services. Once funded, I became a regular employee of Screen as Project Manager.
• I performed the duties listed belo in both roles:
• Co-wrote initial grant and renewal applications, research articles, IRB applications, and reports, and recruitment materials
• Participated in the development of study design and methodology, and data collection tools
• Developed and managed project budget and subcontracts
• Coordinated testing sites, and recruited, screened, and scheduled potential subject study visits
• Administered informed consent process, structured interviews and questionnaires to research participants
• Developed and managed study database and analysis sets
• Designed and implemented data analysis plan and conducted statistical analysis and
• Co-authored reports and manuscripts.

Confidential

Project Director

Confidential Seattle office was downsized. I was offered the opportunity to continue in my position as Project Director at the main office in Bethesda, Maryland. I elected to instead provide contract project management services while remaining in Seattle and devoted the next 8 months to monitoring the TENS Clinical Trial for Lo Back Pain in Veterans, and completing the Cost-Effectiveness of Itraconazole in the Treatment of Oral Candidiasis in HIV Patients study.

The duties I performed as Project Director include:

• Designed, implemented, and managed multi-site drug and medical device clinical trials, clinical and health outcomes, and cost-effectiveness studies
• Conducted clinical trial initiation, monitoring, and close-out visits
• Provided grant and contract budget development and management
• Designed and administered structured and unstructured research participant interviews, and surveys
• Prepared IRB applications and reports
• Managed and participated in the recruitment, enrollment and retention of research participants
• Conducted research participant clinical visits from screening through study completion, including human specimen/sample collection, and monitoring medical status
• Created data collection instruments, and conducted psychometric testing and cognitive debriefing
• Developed and maintained study databases, analysis sets, and data documentation
• Developed and tested comprehensive practice patterns surveys, recruited expert physician panels, and created decision analysis models
• Performed data collection, statistical and economic analysis, client and health outcomes analysis, and interpretation of quantitative and qualitative data
• Provided grant and contract budget development and management
• Designed and administered structured and unstructured research participant interviews, and surveys
• Maintained source documents, regulatory binders, and drug/device accountability records
• Managed project teams of 4 to 10 on- and off-site members
• Scripted and produced video on research subject interviewing and cross-cultural sensitivity in gathering clinical trial data and
• Prepared and assisted in writing reports, manuscripts and presentations.

Project Director

• Directing the projects listed above, I performed the following activities:
• Collaborating in the design, implementation, and daily management of multi-site, state-wide, and national health services research projects
• Providing database and budget development and management
• Conducting data collection, statistical and economic analyses, and interpretation of quantitative CMS and qualitative data
• Managing project teams of 2 to 10 on- and off-site members
• Managing the recruitment, enrollment, assessment, and retention of research participants
• Designing and utilizing self-administered survey instruments, semi-structured telephone interviews, on-line surveys, chart abstraction forms, and text revie indices
• Managing and assigning work to research assistants and support staff
• Performing liaison activities with government and program officials and
• Writing and editing grant and IRB applications, reports, presentations, and manuscripts.

Confidential

Interim Assistant Director

• The various duties I was responsible for in these roles include:
• Managing studies for the Centers for Disease Control and Prevention, The State of California's Department of Public Health, and foundation sponsored planning and evaluation grants
• Leading or assisting with the development and implementation of research study designs and protocols
• Creating study databases, data dictionaries, and analytical data sets
• Analyzing clinical, claims OSHPD , self-reported, survey, and economic data
• Collaborating with local medical providers, health care organizations, government officials, and researchers in conducting research studies
• Developing and editing grant applications, budgets, and IRB applications, modifications, exemptions, and reports
• On- and off-site training and supervision of research assistants and support staff
• Conducted participant recruitment, screening phone calls, and screening and study visits
• Creating and testing data collection instruments and
• Authoring manuscripts, presentations and reports.

Confidential

Research Coordinator

• For this Health Care Financing Administration no Centers for Medicare and Medicaid , evaluation project, I carried out the following tasks as a Research Coordinator:
• Assisted with data cleaning, and performed data entry and data analysis
• Conducted literature reviews
• Assisted in grant, presentation, manuscript, and report preparation.
• Conducted participant screening phone interviews
• Supervised research assistants
• Processed participant/family member referrals from physicians
• Monitored CRF quality and verified accuracy of data against source documents and
• Collected and maintained source documents.