Leah White Email & Phone Number

Raleigh, North Carolina, Us

Clinical Operations Manager for Clinical Research Trials Phase 1-4

North Bethesda, Md, Us

Managed the AMP AD 2.0, within the Neuroscience division, $77million target discovery engine I guide the conduct of major research partnerships with diverse stakeholders including biopharmaceutical companies, healthcare not-for-profit partners, government, and academic scientists. I am responsible for the day-to-day management of specific research initiatives in CNS disorders such as Alzheimer’s disease.

Bethesda, Md, Us

Provide operational expertise to cross-functional project teams, including task/functional managers who oversee the day-to-day operation for other functional areas. Responsible for the conduct and successful performance of clinical trials with expertise in contract-specific system, site reporting, and regulatory documentation review/collection. Provide oversight and mentorship to staff in the delivery of quality work, tasks performance, and timeline management. Plan and manage day-to-day operational aspects of assigned projects including planning, risk management, timelines, and vendor management. Support the Regulatory Support Center (RSC) for the Division of Acquired Immunodeficiency Syndrome (DAIDS) COVID trial. Support NIH Division of Microbiology and Infectious Diseases (DMID) Clinical Research and Operations Management Support (CROMS) with contract-specific tasks. Provide continuous training for staff on Technical Resources International Inc.’s electronic TMF platform, Veeva Vault. Assists in the development and review of corporate SOPs and project-specific procedures (PSPs) to ensure regulatory and client requirements are consistently met. Participates in departmental and project-specific risk assessment (Risk Register) reviews and discussions. Provides subject matter expertise (SME) for ongoing implementation of department systems, e.g., Clinical Trial Management System and Veeva Vault electronic Trail Master File (eTMF) or the use of other sponsor-specific systems, across multiple contracts. Assists with writing and reviewing proposals and forecasting budgetary needs, for government and commercial clients

• Engage clinical sites in the participation of digital therapeutics applications studies through the management of administrative aspects of protocol development, site selection and preparation, site implementation, and continued on-going site assistance • Develop clinical research databases, RedCap, eCRF development, testing, implementation• Synthesize non-profit coalition governance structure and administration documentation and processes• Act as point of contact for sites, to provide training and visitation as needed to support app usage • Consult with sites for areas of training, support or infrastructure improvements

Rockville, Md, Us

Oversee the development of Clinical Practice GuidelinesDeveloped methodology for Clinical Practice Guidelines moving forwardOversee the publication of Journal for Addiction MedicineOversee all publications of ASAM including The ASAM Criteria textbookOversee the ASAM Criteria Level of Care Certification program in collaboration with CARFOversee multiple-member committeesDeveloped new governance for quality improvement committee work.

Bethesda, Md, Us

Oversee the clinical research operations with staff in over 8 different sites around the world who execute over 60 clinical research studies. Oversaw all aspect of Clinical Research Operations in all 7 clinical research areas: Acute Respiratory Infections, Emerging Infectious and Antibiotic-Resistant Diseases, HIV, Deployment/Travel infections, Sexual Transmitted Infections, Skin and Soft Tissue Infection, and Trauma-related infections. IDCRP has the longest and largest Case-Cohort study on HIV.

Washington, Dc, Us

• Synthesized application to Centers for Medicare and Medicaid Services that led to American College of Cardiology being a Qualified Provider-Led Entity • Strategic management of the Appropriate Use Criteria (AUC) Task Force led to a 40% increase in volunteer membership participation and activities• Managed the Appropriate Use Criteria Team• Assembled AUC Summit, a national meeting, a relationship building conference attended by over 60 external stakeholders including Centers for Medicare and Medicaid Services• Generated the contract licensing structure for AUC content• Negotiated and executed all AUC contracts• Oversaw the publication of 6 clinical policies, an increase of 600% from previous two years• Reduced timeline to publication by 40% by utilizing technology to update methods • Oversaw and contributed to the development of AUC procedures, including criteria development and implementation• Synthesized multiple Quality Improvement AUC tools, and coordinated with National Cardiovascular Data Registries and Advocacy divisions• Led Science and Quality Committee, as staff liaison, which oversees ACCs clinical quality initiatives • Constructed SOPs, with active worksheets and recommendations on AUC development for volunteer members and staff• Designed new policy practices to assess which new documents are to be started and staff resources to be allocated• Evaluated current practices to refine processes for efficiencies including the utilization of cloud-based software for surveys and project management • Increase utilization of volunteer members, while decreasing the cost• Evolution of the AUC development process to include project scope development, creation of serial documents, refined recommendations for activities of volunteer members• Formed working groups with partnering organizations who attended the AUC Summit to increase our reputation and visibility in the area• Redesigned the AUC website

Washington, Dc, Us

• Assembled the LDL: Address the Risk 2015 Think Tank, which brought together over 50 key stakeholders to discuss combination therapy for dyslipidemia• Executed Very High Triglycerides Positioning Meeting, which brought in key stakeholders to discuss the risks and treatments for very high triglycerides• Served as project manager for a new program to bring policy and physician decision pathways to novel technology• Led the Clinical Quality Committee as staff liaison, which oversees ACCs clinical quality initiatives • Collaborated with LDL: Address the Risk workgroup and ACC staff to develop and promote the Statin Intolerance App

Bethesda, Md, Us

• Executed the startup of the first AGA Clinical Research Registry evaluating treatment options and cost of care for gastrointestinal diseases as both the program and project manager • Identified and rectified errors in an existing budget proposal which saved the association over $302,000 • Honored with award for my work writing, budgeting, and submitting grant to National Institutes of Health Division of Infectious Diseases and AIDS • Implemented new technology standards and programs to manage projects and clinical research• Negotiated the execution of over 20 contracts: ranging from Confidential Disclosure Agreements to Master Service Agreements, Site Contracts, etc. • Led four volunteer physician groups including the Registry Oversight Committee• Managed and verified the regulatory study start-up of 20 sites • Applied policy and laws related to clinical research, consulted on related policy• Managed, monitored, audited, and evaluated all clinical research protocols to ensure compliance with federal & state laws and ethical considerations• Prepared submissions to local and national Institutional Review Board• Developed & ensured electronic case report forms met Clinical Data Interchange Standards Consortium requirements• Monitored site data entry to ensure quality• Developed the infrastructure, established and maintained timelines• Wrote new manual of over 15 standard operating procedures• Created and edited ClinicalTrials.gov listings • Developed & monitored budgets• Managed contracts, work products and relationships with outside vendors• Developed & managed a publication process• Developed request for proposals (RFPs) to support registry development and management, as necessary.• Coordinated with AGA Communications & Marketing departments to promote registry activities and relationships, as appropriate• Wrote and edited articles for all appropriate AGA multimedia communication vehicles

Rockville, Md, Us

• Assistant to Deputy Chief of Party, Feed the Future FEEDBACK a USAID program• Assisted with the management of five regional coordinators; • Prepared and ensure the quality of deliverables, • Managed daily activities, organize and manage professional working groups, • Managed and trained staff on online project management software• Managed a team in the development of the International Clinical Regulatory Research Matrix as contracted by the NIH/NIAID/Division of Aids (DAIDS)• Provided project management and reporting structures for deliverables• Executed conflict management skills when problems arose • Aided staffing decisions after funding was cut from Federal Budget

Rockville, Md, Us

• Managed a team of four in the development of the International Clinical Regulatory Research Matrix as contracted by the NIH/NIAID/Division of Aids (DAIDS)• Provided project management and reporting structures for deliverables• Executed conflict management skills when problems arose • Aided staffing decisions after funding was cut from Federal Budget

Columbus, Oh, Us

• Managed, monitored, audited, and evaluated all clinical research protocols to ensure compliance with federal and state laws and bioethical considerations• Prepared submissions to local and national Institutional Review Board• Monitored clinical trial data for more than 10 NIH or Principle Investigator Initiated Trials• Developed Cardiovascular Fellows Research Training Support Initiative • Audited billing, payments, and invoices system • Identified a $25,000 error in a single study• Developed, implemented, and maintained internal data collection methods • Developed and negotiated budgets and execution of contracts• Submitted and coordinated of research billing methods with Center for Medicare and hospital billing• Acted as clinical research coordinator for Principle Investigator Initiated Trials as needed• Evolved new standard operating procedures, and updated older procedures • Constructed budgeting and revenue tracking methods/system • Managed ClinicalTrials.gov listings for Principal Investigator initiated trials • Monitored and reviewed financial status of projects through the Research Foundation• Organized and maintained the unit’s International Air Transport Association training for compliance with shipping biohazards law• Maintained and updated unit’s website

Columbus, Ohio, Us

Focus in Prevention and Sports Cardiology Protocol creation and submission to Internal Review Board Continuous submission of Institutional Review Board documents Study enrollment and retention Data collection and analysis Survey creation, distribution and collection Review, organized, and updated Standard Operating Procedures

Toledo, Oh, Us

• Focus in Headache and Migraine • Protocol creation and submission to Internal Review Board• Continuous submission of Internal Review Board documents• Study enrollment and retention• Data collection and analysis• Survey creation, distribution and collection• Data collect and monitoring for Joint Commission on Healthcare Organization of clinical and research procedures

Master Of Public Health (Mph), Public Administration

Bach Of Science, Applied Health Science