Shari THOMPSON
ALEXANDRIA,VA
Summary
Strong in developing implementation strategies with regards to policy, regulation, and technical processes. A broad-based thinker who utilizes all resources to engage and meet or exceed stakeholders’ expectations. A record of being a critical thinker, who is a team member on every programmatic level, listens to different perspectives and then implements clear and concise plans as needed. Experienced at leveraging gained knowledge and past relationships to impact organizational strategic plans. Love to brainstorm with teams and no problem resolving issues. Introduced ROI data capture, now required and used to inform leadership decision making. A full understanding of the research enterprise from working in the US Federal Government, For Profit, University environments, and consultancy.
Overview
39
39
years of professional experience
2
2
Certifications
Work History
Research Analyst
George Washington University
Washington, DC
12.2016 - Current
- Administer programmatic oversight and engagement with GW faculty to increase internal and external research proposal submissions.
- Provide programmatic, conceptual, and analytic support for the university's research development activities.
- As a SME, evaluate programmatic needs for cloud-based technology deployment and AI uses.
- Conduct technology use training sessions for academic and administrative audiences.
- Increase administrative activities and programmatic efficiencies through qualitative and quantitative data analyses.
- Build internal and external collaborative teams.
- Identify resources to acquire knowledge, skills, and abilities required to conduct research.
- Analyze the funding landscape to advise faculty on advantageous opportunities and sponsors.
- Provide support and follow-up with early-career faculty working on first research proposals.
- Track and monitor the development of complex grant and contract proposals.
- Interact with internal and external committees, groups, and organizations to ensure compliance with established research compliance standards.
- Negotiate contracts and agreements, and manage consultants and vendor activities.
- Develop and improve communications in programmatic and administrative areas.
- Conducts comprehensive data analysis to support research initiatives.
- Collaborates with leadership on project development and implementation strategies.
- Manage research output and data to identify relevant studies and findings.
- Analyze qualitative and quantitative data, utilizing statistical software tools.
- Prepare research reports and presentations for conferences, workshops, and training sessions.
- Manage project timelines, and coordinate tasks among teams and collaborators effectively.
- Support grant applications by compiling relevant information and documentation.
- Review existing research to identify future directions.
- Utilize tools such as Excel spreadsheets and databases for data manipulation and analysis.
- Monitor funded grants to keep abreast of research focus and trajectory.
- Assisted the research business office by providing research-based inputs for external surveys and assessments.
- Develop ROI data capture and metrics to inform decision-making processes.
- Determine best methods to meet research objectives such as reduce workload and produce useful data.
Special Opportunities & Program Projects Officer (Exploratory Position)
Georgetown University
Washington, DC
07.2015 - 10.2016
- Deployed methods to increase sponsored research proposal submissions.
- Developed complex program project collaborations across GU campuses and external research groups.
- Assisted PIs and research development offices through grant proposal development and award management lifecycle.
- Reviewed sponsored research proposals for intellectual property possibilities.
- Formed multidisciplinary and interdisciplinary collaborative research teams.
- Facilitated meetings with faculty to discuss departmental and sponsored project issues.
- Managed communications between research leadership and project teams effectively.
- Disseminated changes in federal and institutional policies and regulations.
- Provided cloud-based platform technology training to faculty and staff.
- Provided education on pre-award processes to faculty and staff.
Office of Director (Temp)
National Institutes of Health (NIH)
Bethesda, MD
10.2014 - 01.2015
- Provided programmatic and administrative support in logistics, coordination, facilitation and organization to the Office of Strategic Coordination during implementation of organizational restructuring and expansion processes.
Sr. Scientific Program Administrator & Public Health Analyst
National Institute of Mental Health/NIH
Bethesda, MD
12.2003 - 09.2014
- Provided oversight and support for strategic initiatives in the Genes, Cognition, and Psychosis Program.
- Aided in the strategic planning of programmatic structure and staff function.
- Evaluated programmatic need for services, resources, and strategy implementation.
- Disseminated and managed federal directives related to regulations, policies, and procedures.
- Increased administrative and programmatic efficiencies through qualitative and quantitative data analyses.
- Directed non-federal, multidisciplinary teams (domestic and international) to meet programmatic strategic plans.
- Managed research and administrative collaborations.
- Improved communication flow in programmatic and administrative areas.
- Implemented DHHS policies and regulations for research-related data collection and acquisition.
- Edited reports, manuscripts, and presentations.
- Managed manuscript publication procedures, review status, and reported publication analytics.
- Managed budget forecasts, tracking, financial data analyses, and reporting.
- Developed an auditing system to track and monitor research, clinical procedures, and projects.
- Managed domestic clinical trial sites and international collaborative clinical research sites.
- Managed regulatory documents, protocols, consent forms, manuscripts, and research data.
- Ensured confidentiality and secured all documents and information as per regulations.
- Managed budgets, vendor service contracts, intellectual property, and other agreements in support of preclinical and clinical studies.
- Managed government assets.
- Adeptly navigated government data warehouses and enterprise systems.
Clinical Research Manager
Penn Medical Laboratory/MedStar Research Institute
Hyattsville, MD
12.2000 - 10.2003
- Coordinated efforts of clinical studies on coronary artery disease.
- Managed lab operations for funded research on atherosclerosis, from study trial inception through close out during a lab reorganization.
- Developed a biospecimen inventory, storage, retrieval, and disposal database.
- Implemented a barcode system to track sample location, and document sample quantity to improve clinical study audit activities.
- Developed auditing systems and methods to track and monitor study procedures to reduce redundancies, improve workflow, and enhance accountability.
- Developed and managed specimen accessioning and processing procedures, data management (LIMS), analyses, and reporting.
- Supervised research, clinical trial site study coordinators, phlebotomists, and technicians.
- Assisted in the development of preclinical and clinical study protocols, study proposals, and IRB submissions.
- Created operations manuals and study test kits for trial sites.
- Maintained regulatory source documents and study trial files.
- Presented reference lab procedures at investigators' meetings and staff training programs.
- Served as a clinical research business manager, compliance officer, client services liaison, and financial manager.
- Maintained CLIA and CAP accreditation.
- Ensured the implementation of GLPs, established a quality control program, and created SOPs for regulatory compliance.
Clinical Research Associate Project Manager
George Washington University School of Public Health and Veterans Administration Hospital
Washington, DC
07.2000 - 04.2002
- Managed a clinical research trial and grant that supported a study to define the parameters of symptoms for Persian Gulf War Syndrome.
- Managed budget, acquisitions, accounts, and professional service agreements.
- Learned and administered the computerized SCID (Structured Clinical interview of DSM-IV) psychiatric interview, to veteran volunteers.
- Determined psychiatric diagnoses by conferring with the study psychiatrist, the SCID analysis and description of study participant's affect.
- Developed protocol, informed consent form, regulatory documents, operations manual/SOPs.
- Implemented IRB and regulatory actions.
- Performed AE/SAE reporting.
- Compiled data for post-award and compliance reporting.
- Performed site monitoring and closed out.
- Aided in manuscript development.
Human Subject Protection Specialist (Consultant)
Office of Regulatory, Compliance, and Quality/DOD
Frederick, MD
04.2000 - 06.2000
- Worked in conjunction with a second-level Institutional Review Board (IRB) for the assessment of military and congressionally directed research projects involving human subjects.
- Provided support to PIs for research protocol pre-IRB review, application of IRB policies and procedures, human subject protection education, and federal assurances.
- Identified human subject use issues.
- Outlined strategic plans to navigate protocols for human subject approval and conduct.
- Documented decision-making process for study protocol evaluation (risk/benefit analysis).
- Ensured site adherence to federal regulations, policies, protections, and principles.
- Presented to the IRB, research protocols with informed consent forms marked with stipulations, recommendations, and risk/benefit analysis.
- Served as an education specialist on Human Subject Protection regulations to PIs.
- Analyzed compliance of protocols and consent forms to the Common Rule.
- Analyzed compliance with FDA regulations, policies, and guidelines to identify human subject protection issues.
Clinical Research Associate (Remote)
First Circle Medical, Inc. and George Washington University
Bowie, MD
03.1999 - 03.2000
- Managed clinical trial sites studies of extracorporeal whole-body hyperthermia perfusion to treat end-stage HIV, Hepatitis C, and small cell lung cancer patients as part of a medical device new indication for an FDA new medical use application.
- Managed the on-site study at George Washington University.
- Coordinated research activities with an emphasis on project management, funding, financial management, business development, and expansion.
- Conducted site visits to monitor compliance with study protocols.
- Collaborated with investigators to ensure data integrity and accuracy.
- Reviewed and approved case report forms for completeness and clarity.
- Managed regulatory submissions to maintain study timelines and requirements.
- Participated in team meetings to discuss project updates and challenges.
- Documented findings in trial master files to ensure audit readiness.
- Performed interim monitoring and study close-out visits while collecting regulatory documentation.
- Reported to project manager for issues related to overall study status.
Clinical Research Coordinator (Remote)
United Services Clinical Research, Inc
Augusta, GA
09.1997 - 04.1999
- Multi-site Phase II Randomized Placebo Controlled Double-Blind Clinical Trial (IND submission-Viagra) in the Department of Urology at Veterans Hospitals in Augusta, GA and Baltimore, MD.
- Successfully met implementation plans and achieved milestones as per study scheme.
- Completed and managed documents for the trial master file and site source documents.
- Completed and filed all IRB documents and AE/SAE Forms and Follow-up.
- Facilitated all aspects of clinical trial monitoring, auditing, and follow-up events.
Acting CEO (Family - Owned)
Metro Non-Emergency Transportation, Inc
Atlanta, GA
11.1994 - 08.1997
- Having no prior working knowledge or experience in this job, I successfully managed a staff of 12.
- Developed financial and public relations policies.
- Developed a business structure and regulations.
- Implemented operational procedures, QC standards, and managed daily operations.
- Established an operational system for securing confidential, non-emergency medical transportation records.
- Successfully developed and compiled documents for a scheduled IRS audit of 10,000 Medicaid transportation records.
Sr. Research Technician
George Washington Univ. School of Medicine & NIH
Washington, DC
05.1994 - 10.1994
- Successfully evaluated immunogenic responses to HIV-specific antigens in vivo.
- Injected adjuvants into the host, bled weekly, and measured the immune response in rabbits.
- Used a cytotoxic T-lymphocyte assay to determine the vaccine adjuvant's long-term potential.
- Performed qualitative analyses via ELISA methodology.
Sr. Research Technician
NIAID/NIH
Frederick, Maryland
01.1988 - 05.1994
- Supported PI to develop, conduct, and evaluate the efficacy of camptothecin and topotecan as inhibitors of HIV infection.
- Designed and tested methods for eliminating the spread of HIV in T-lymphocytes through recombinant retroviral constructs containing an acyclovir target.
- as part of Masters thesis, DI developed a method to discover at which time point in the HIV infection process a test compound protects against infection, as evidenced by the XTT assay.
- Designed a methodology for studying the kinetics of HIV infection in CEM cells in vitro, using a non-isotopic in situ hybridization procedure.
- Established a method to synchronize CEM T4 cells into the G0 cell cycle phase in vitro.
- Received an award of $2,500 for developing a program for the Biomek 1000 automated liquid handling system, significantly reducing the lab's annual expenditure for 96-well pipette tips.
- Promoted to trainer for testing the most viscous organic compounds in the anti-HIV drug screening lab.
- Successfully performed daily duties in the Anti-HIV Drug Screening Laboratory, including setup, stock preparations, reading results, and data analysis.
- Daily, maintained laboratory source documents and equipment.
Sr. Microbiologist
Department of Bacteriology, National Health Laboratories
Vienna, Virginia
02.1987 - 04.1988
- Performed diagnostic tests in microbiology, bacteriology, serology, and chemistry on patient biological specimens.
- Established a new fluorescent microscopy lab and procedure for chlamydia diagnostic tests.
- Successfully developed chlamydia diagnostic testing standard operating procedure, from sample setup to results.
- Trained medical technologists to perform the chlamydia fluorescent test procedure, and determine microscopic test results.
- Performed state proficiency surveys and blind sample test evaluations.
- Due to sample testing efficiency, I assisted the departments of Serology and Chemistry in reducing the patient sample testing backlog.
Education
Biomedical Research - Virology
Hood College
Frederick, MDMicrobiology -
Southern Illinois University
Carbondale, ILSkills
- Program & Project Management
- Programmatic Development and Evaluation
- Federal Regulatory & Policy Compliance
- Budget & Contract Development
- Data & Records Management
- Technology/Innovation Deployment/Management
- Communications
- Facilitation and Logistics
- Database and Computer Management
- Procurement and Acquisitions
Affiliations
Research Administration Certification Council (RACC), since 2016
Certification
Research Administration Certification Council (RACC), #2015203354, since 12/31/2016
Training
- National Institutes of Health National Annual Conferences
- National Science Foundation National Annual Conferences
- NCURA Horizon 2020, Washington, DC
- Howard University RCMI-Joint Team Science Symposium, Washington, DC
- NIH Regional Seminar, Baltimore, MD
- ICH GCP Training, Bethesda, MD
- The Essentials of Project Management, Bethesda, MD
- SharePoint, Bethesda, MD
- FDA 101: Why, What and How To of Drug Development (I2I Series), Washington, DC
- Protection of Human Subjects, Bethesda, MD
- Federal Records Management for Everyone, Bethesda, MD
- Ethics and Regulatory Issues of Clinical Trials, Bethesda, MD
- Management of Clinical Trials Finances, Clinical Research Site Training, Philadelphia, PA
- Management of Clinical Trials, United Services Clinical Research, San Antonio, TX
Presentations
- NCURA 66th Annual Meeting – National Conference, Measuring Internal Grant Program Effectiveness, Co-Presenter, 90min, Washington, DC, 08/2024
- InfoReady Corporation – National Webinar, How InfoReady Progress Reports Informs Institutional Return on Investments (ROI), Presenter, 90min, 09/2022
- InfoReady Corporation – National Webinar, InfoReady Review Multitrack Template, Presenter, 90min, 02/2021
- Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) Consortium - Grant Writing Seminar, PIVOT, Presenter, 1hr, Washington, DC, 2020
- SRA International Chesapeake Chapter, Are Intramural Competitions Weighing You Down? Lighten Up By Using Technology, Presenter, 1hr, Stevenson University, Pikesville, MD, 06/2019
- InfoReady Corporation – National Webinar, In Their Own Words: Limited Submissions, Co-presenter, 90min, 11/2018
- SRA International Chesapeake Chapter, Navigating the Waters of Building International Research Collaborations, Presenter, 1hr, Georgetown University, Washington, DC, 06/2017
- Georgetown University CRA Examination Training Session, Pre-Award, Presenter, 1hr, Georgetown University, Washington, DC, 08/2016
- SRA International Chesapeake Chapter, Become a Better Leader, Presenter, 1hr, Georgetown University, Washington, DC, 06/2016
- GHUTTS Grant Writing Seminar Series, Creating a PIVOT Account and Finding Funding Opportunities, Presenter, 90min, Washington, DC, 06/2016
Timeline
Research Analyst
George Washington University
12.2016 - Current
Special Opportunities & Program Projects Officer (Exploratory Position)
Georgetown University
07.2015 - 10.2016
Office of Director (Temp)
National Institutes of Health (NIH)
10.2014 - 01.2015
Sr. Scientific Program Administrator & Public Health Analyst
National Institute of Mental Health/NIH
12.2003 - 09.2014
Clinical Research Manager
Penn Medical Laboratory/MedStar Research Institute
12.2000 - 10.2003
Clinical Research Associate Project Manager
George Washington University School of Public Health and Veterans Administration Hospital
07.2000 - 04.2002
Human Subject Protection Specialist (Consultant)
Office of Regulatory, Compliance, and Quality/DOD
04.2000 - 06.2000
Clinical Research Associate (Remote)
First Circle Medical, Inc. and George Washington University
03.1999 - 03.2000
Clinical Research Coordinator (Remote)
United Services Clinical Research, Inc
09.1997 - 04.1999
Acting CEO (Family - Owned)
Metro Non-Emergency Transportation, Inc
11.1994 - 08.1997
Sr. Research Technician
George Washington Univ. School of Medicine & NIH
05.1994 - 10.1994
Sr. Research Technician
NIAID/NIH
01.1988 - 05.1994
Sr. Microbiologist
Department of Bacteriology, National Health Laboratories
02.1987 - 04.1988
Biomedical Research - Virology
Hood College
Microbiology -
Southern Illinois University