Tara Schweizer Email & Phone Number

• Hired and led an agile team focused on trial delivery technologies and processes. Digital solutions in use/development included: CTMS; QMS; LMS eCOA; (eSource; ePRO; clinical devices); patient portal; and scheduling.
• Led the strategy, design, implementation, and validation of protocol specific eSource within Epic and later CRIO- to enable compliant/standardized data collection for decentralized trials at 57+ distinct trial sites.
• Guided the establishment of a computer system validation (CSV) infrastructure that included processes, templates, and committees to achieve/maintain 21 CFR Part 11 compliance.
• Created and implemented a technical support and iterative training strategy for a network of over 70 sub-investigators that spanned virtual and physical research sites across the US.
• Successfully communicated strategy, complex business needs, and related regulatory requirements to adjacent enterprise executives; solutions architects; business analysts; program managers; and developers.
• Reconfigured eISF tool and workflows; reduced administrative burden by 10X and enabled centralized management for multi-site trials under multi state principal investigators.

AdventHealth Research Institute provides centralized research support to over 400+ Investigators; ~600+ active studies annually; in eleven distinct therapeutic areas.

• Conducted world-class research targeting diabetes, obesity, the metabolic origins of cardiovascular disease and aging; specializing in proof-of-concept and mechanism studies through National Institute of Health (NIH).
• Lead Data Management, developed strategy, assigned responsibilities, & managed day-to-day operations to support data collection/transmission.
• Oversaw all clinical data management deliverables, including budgets; data management plans; data transfer agreements; data transfer specifications.
• Represent the Institute as the lead clinical data manager (CDM) for, site initiation visits (SIV); monitor visits; study start up; and protocol kick off meetings.
• Instituted quality assurance (QA) initiatives and Quality Control (QC) measures to ensure data integrity- across all data generating Cores, e.g. imaging, calorimetry, metabolic kitchen, exercise & bioenergetics, and lab.
• Active leader on the Quality Committee- and consulted by the Medical Oversight Committee.

• Drafted Clinical Data Management Plans (DMP), for both FDA & NIH Studies.
• Collaborated with global KOLs (Key Opinion Leaders, Physician-Scientists) to ensure systematic data collection of scientific and safety endpoints.
• Designed electronic source & electronic case report forms (eSource/eCRF); including edit checks and range limits.
• Authored SOPs to achieve regulatory compliance for electronic systems and data management practices.
• Managed User acceptance testing (UAT) and Unit Testing for various clinical trial applications.
• Developed a distributed approach to data entry- across multidisciplinary data generating research Cores. e.g. Medical Imaging, inpatient clinic, metabolic kitchen, calorimetry unit, clinical laboratory, etc.

Orlando, Florida, United States

• Documented scientific endpoints and research objectives for electronic case report form design (eCRF).
• Designed electronic Source and Electronic Case Report forms (eSource/eCRF) within Cerner EMR.
• Facilitated training and system access. Participated in unit testing.
• Coordinated the implementation of vendor/sponsor software and related hardware.
• Managed institute’s relationship with enterprise IT. Created strong partnerships via trust and transparency.

Master'S Degree, Health Informatics

Bachelor Of Arts (B.A.), Environmental Science