Stephanie Smith
Cedar City,UT
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Lead Clinical Research Associate
University of Southern California, Keck School of Medicine
2019.01 - Current
- Assign and track weekly goals for data cleaning for the clinical monitoring team
- Assign and track clinical monitoring visits across multiple teams
- Perform on-site and remote monitoring visits at study sites, to include, Site Selection, Site Initiation, Interim, and Close-out Monitoring Visits
- Ensure essential documents are present, accurate, and maintained in the site study files and the Sponsor study files
- Site management to ensure adherence to the study protocol, study manuals, and applicable regulations and that the study site is meeting the trial timelines
- Train study staff on study specific structured clinical interviews and ensure they are being conducted, scored, and reported accurately
- Perform 100% SDV remotely and at study sites to ensure data is accurate and complete, giving special attention to primary outcome measures, as well as safety measures
- Perform IP accountability, including appropriate documentation of receipt, preparation, dispensation and return of IP and ancillary products and that there are no deviations to the IP storage requirements
- Train study staff, as needed, and ensure the site staff and facilities remain adequate to conduct the study throughout the trial.
- Distilled large amounts of information and produced reports, spreadsheets and documents outlining key details.
Research Project Manager
Advanced Brain Monitoring, Inc (Carlsbad, CA)
2017.04 - 2019.01
- Managed multiple (>4 simultaneous) federally funded clinical research initiatives (NIH, DARPA)
- Management of IRB submissions and approvals for 10 studies
- Performed Site Initiation Visits and Site Training on study protocols, procedures, and required documentation
- (6 studies, 15 Sites)
- Managed and trained the Sponsor Research Team (17 CRAs, 20 CTAs)
- Identified and managed KOL relationships in therapeutic areas such as Alzheimer's Disease/dementia, sleep medicine, HIV, and spinal cord injury
- Implemented and maintained compliance with Clinical Trial SOPs/Quality system
- Presented research findings at 7 industry relevant conferences.
- Worked well in a team setting, providing support and guidance.
- Worked effectively in fast-paced environments.
Lead Clinical Research Associate
Advanced Brain Monitoring
2015.07 - 2019.01
- Developed literature reviews for >100 publications
- Supported >13 publications as a co-author
- Developed Site training materials for 6 studies and company training
- Documented development and assisted in the development of study designs for 12 studies
- Developed essential documents (ICF, CRF, protocol) for 5 studies.
Clinical Research Technician
Advanced Brain Monitoring
2015.01 - 2015.07
- In house expert on all EEG systems used in clinical research studies
- In house expert on neurophysiology signal data management
- Managed recruitment and Protocol execution across 6 studies, >400 participants
- Data Management for 6 studies.
- Supervised data collection by core research staff.
- Kept supplies organized and well-stocked, requesting more supplies and avoiding unnecessary testing delays.
- Maintained safe work environment free of unnecessary hazards to protect staff and testing results.
Education
BS- Kinesiology- Pre-Physical Therapy -
California State University-San Marcos
San Marcos, CA12.2014
Associate of Science - Pre-Nursing/Pre-Medicine
Yavapai Community College
PrescottAssociate of Arts - Social And Behavioral Sciences
Palomar Community College
San Marcos, CA05.2007
Skills
- Clinical Research
- Progress Reporting
- Project Management
- Documentation Abilities
Certification
- CITI Protecting Human Research Participants
- CITI Good Clinical Practice
- CITI Social & Behavioral
- Responsible Conduct of Research
- A.E.D, C.P.R, First Aid EMT (2009)
- CNA (2007)
Presentations And Publications
- EEG Signatures Associated with Resting State, Memory and Attention As Potential Reliable Biomarkers of Cognitive Decline in Alzheimer's Disease, Alzheimer's Association International Conference, 2019, Los Angeles, California
- Neurophysiological Indices of Cannabis and Impairment, Society for Neuroscience, 2018, San Diego, CA
- Cannabis and Driving: Assessing Neurophysiologic and Performance Deficits, Manuscript in Preparation
- Transcranial Impedance Changes During Sleep: A Rheoencephalography Study, Manuscript in Preparation
- Neurophysiological Indices of Human Social Interactions between Humans and Robots, Manuscript in Preparation
- EEG Event Related Potentials in Sustained and Focused Attention tasks: Potential Biomarkers for Cognitive Decline in HIV Patients, Manuscript in Preparation
- EEG-Based Neurocognitive Metrics May Predict Simulated and On-Road Driving Performance in Older Drivers, Manuscript in Preparation
- Neurophysiological Biomarkers for Alzheimer's Disease (AD) & Mild Cognitive Impairment (MCI) Acquired During Sleep & Waking, AAT- AD/PD, 2018, Torino, Italy
- Characterization of Sleep Abnormalities in Alzheimer's Disease (AD) & Mild Cognitive Impairment (MCI) Using and In-Home Sleep Profiling System, ADPD, 2018, Torino, Italy
- Neurophysiological Indices of Human - Robot Interactions, Society for Neuroscience, 2016, San Diego, CA
- Heart-Rate Variability and Power Spectral Densities as Neurophysiological Indices of Post-Traumatic Stress Disorder, Society for Neuroscience, 2015, Chicago, IL
- Psychophysiological Effects of Adderall Use, 55th Annual Meeting of the Society for Psychophysiological Research, 2015, Seattle, WA
- Combined Neurocognitive & EEG Biomarkers to Assess Effects of CNS Depressants & Stimulants, ASCP, 2015, Las Vegas, Nevada, United States
Timeline
Lead Clinical Research Associate
University of Southern California, Keck School of Medicine
2019.01 - Current
Research Project Manager
Advanced Brain Monitoring, Inc (Carlsbad, CA)
2017.04 - 2019.01
Lead Clinical Research Associate
Advanced Brain Monitoring
2015.07 - 2019.01
Clinical Research Technician
Advanced Brain Monitoring
2015.01 - 2015.07
BS- Kinesiology- Pre-Physical Therapy -
California State University-San Marcos
Associate of Science - Pre-Nursing/Pre-Medicine
Yavapai Community College
Associate of Arts - Social And Behavioral Sciences
Palomar Community College
- CITI Protecting Human Research Participants
- CITI Good Clinical Practice
- CITI Social & Behavioral
- Responsible Conduct of Research
- A.E.D, C.P.R, First Aid EMT (2009)
- CNA (2007)
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