James LeVangie
Clinical Study Manager at Neural Analytics- Claim this Profile
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English Native or bilingual proficiency
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Spanish Elementary proficiency
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German Elementary proficiency
Topline Score
Bio
Credentials
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HIPPA Certification
CITIAug, 2014- Oct, 2024 -
Good Clinical Practices
CITIMar, 2015- Oct, 2024 -
Human Subjects Research – Biomedical Basic
CITIMar, 2015- Oct, 2024 -
40-hour HAZWOPER
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CPR and First Aid Training
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Forklift Operator
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Portable Nuclear Gauge
APNGA
Experience
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Neural Analytics
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United States
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Medical Practices
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Clinical Study Manager
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May 2017 - Present
mTBI Analytical Platform Development StudyProject funded by $3M NIH NINDS SBIR Phase II grant to investigate cerebral blood flow velocity (CBFV) changes following mild traumatic brain injury. Technical objective of developing analytical platform to detect and monitor mild traumatic brain injury (mTBI) based on transcranial Doppler (TCD) ultrasound measurements with supporting MRI and clinical evaluation labels.Study Start Up and Management• Developed clinical trial protocol, informed consent, advertising materials, and other study materials and managed trial master file to ensure compliance with GCP and ICH E6.• Coordinated site preparation activities to initiate start up of study.• Conducted device and research tool training with site staffRecruitment and Enrollment• Over 170 subjects enrolled in two and a half years. Subject recruitment activities included attending fairs, publishing study flyer in school and local papers, handing out flyers at community centers, discussing with local high school athletic programs and sports medicine clinics.• Proctored study procedures in clinic and research room settings to ensure protocol compliance and data quality objectives met.Monitoring• Monitored site to ensure human subject protections, protocol compliance, and audit readiness.• Performed 100% source document verification to ensure data quality and integrity prior to submission of data to FITBIR, analysis, and use in publications.Data Management• Directed project’s data management and used internal EDC software to save company costs of using third party vendor. • Worked with FITBIR data administrators to develop and publish first TCD form structure in FITBIR data repository. Coordinated study data submission leading to shared TBI data with broad research community. Show less
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Clinical Specialist
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Jan 2019 - Present
CODEX Device Feasibility StudyFeasibility study concerned with application of automated TCD signal acquisition system on various neurological conditions (ex: stroke, aneurysm, PFO, ICP, etc.). Device Training and Proctoring• Conducted presentation to site study team to introduce investigational device and educate on its capabilities and functionality. • Successfully trained and proctored three TCD naive users on how the device works. First through hands on training in a controlled practice environment. Later proctoring of case in neurocritical department resulted in first patient in during site initiation visit. • Worked with clinical project manager, medical science liaison, and sales representative during SIV to ensure all three trainees received appropriate education on study device, study protocol, and answered all questions.• Assisted with the development of training materials and training plan for new site and device configuration. • Provided supplemental TCD educational materials to site to help with site engagement and help improve their device operation and application skills.• Ensured site was able to transfer study data by setting up and sharing cloud-based file sharing folder. Show less
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Clinical Specialist and Clinical Research Associate
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Oct 2016 - Present
EXPEDITE I & II Stroke StudiesFeasibility study of TCD waveform analysis on patients with acute LVO. Later, first in man, device feasibility study of an automated TCD signal acquisition system.Study Start Up and Management• Assisted with customization of portable, cart-based TCD system to facilitate system use in emergent care environment. • Assisted with study start up activities like protocol, ICF, and CRF development to help start the project on time.• Facilitated device release request from Engineering Department and shipping to site. Obtained approvals and signatures from Engineering, QARA, Clinical, and Data Science departments to ensure device being shipped meet the appropriate company and department policy requirements.• Assisted with the development of the device user manual to ensure research staff were properly instructed and trained on device use.Data Acquisition• Visited site for one month to help perform data collection in emergency department with new device and give feedback on workflow feasibility to improve study operations as well as device functionality. Show less
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Technician, Clinical Research Associate, and Data Collection Team Manager
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Aug 2014 - Jun 2017
Project MIND (Measuring Intracranial Neurological Disorders)Feasibility/proof of concept study focused on acute mild traumatic brain injury (mTBI). Goal was to develop analytical platform for detecting changes in cerebral blood flow velocity following concussion as well as track recovery.Study Start Up and Management• Assisted with protocol and ICF development.• Obtained and maintained IRB approval of all study documents to ensure that human subject safety protections and good clinical practices were followed.Recruitment and Enrollment• Served as part of team, then later as manager, that performed over 2,000 TCD scans on approximately 1,300 subjects. Participants ranged from high school athletes to elderly adults. • Partnered with seven Los Angeles and Orange County sports medicine specialist and pediatricians, six high school athletic departments, and three community centers to increase subject recruitment pool and study awareness.• Recruitment efforts included meeting with physicians, community leaders, teachers, and coaches. Grass roots recruitment by engaging strangers to inform them of study. Posted Craigslist advertisements. Attended Friday night games and Saturday morning clinic to capture athletes close to time of injury.Data Collection Team Manager• Managed approximately 10 TCD technologist to drive subject recruitment and data acquisition. • Mentored new staff to take on additional roles leading to better team member input and progress toward data collection team goals.• Improved on TCD training course by adding training phases, improving educational material, hiring outside instructors, and providing staff opportunities to attend conferences.• Contributed to the development and implementation of a mobile research center to solve the time and space conflict in crowded doctors’ offices. The mobile research center allowed the research team and the subject’s flexibility to when and where to schedule appointments. Show less
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The Palladino Company, Inc.
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United States
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Environmental Scientist, Santa Susana Field Laboratory Radiological Investigation
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Jun 2010 - Jul 2014
Conducted surface gamma scanning with state of the art detection systems, offering full gamma spectrum analysis with high accuracy GPS, over a 471 acre area consisting of very rough terrainDeveloped and conducted a study to determine the effects of soil moisture on gamma ray attenuation in surface soil; analysis of results indicated the maximum acceptable soil moisture during gamma scanningPerformed soil, sediment, and water sampling in rugged terrain and marked locations with GPS/GIS Maintained quality control database for radiation detection systemsEnsured data quality objectives were met by validating analytical laboratory data for soil samplesManaged laboratory data package validation status to improve throughput for hundreds of data packages for numerous radiochemical analysesDeveloped strong working relationships with Biological, Archaeological, and Native American Monitors to minimizing the impact of investigation activities on natural and cultural resourcesAssisted with developing plans, reports, and presentations Show less
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Environmental Scientist, START Region 9
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2012 - 2012
Conducted radiological investigations of home sites on the Navajo Nation for uranium contamination by surveying with the EPA’s Rapid Assessment Tool (RAT) to delineate extent of contaminationGuided removal actions of contaminated soil by spot checking with hand held detector and RAT system to ensure soil had been sufficiently removed or back-filledReported progress to EPA by submitting daily activity reports
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Graduate Student Teaching Assistant
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Sep 2007 - Aug 2009
Prepared and lead discussion and laboratory sections of 20 to 25 students for General and Environmental chemistry courses Demonstrated basic laboratory techniques to students and ensured safety of laboratory classroom Simplified complex scientific ideas using daily-life analogies to make material easier to understand
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Graduate Student Research Assistant
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Sep 2007 - Aug 2009
Performed cutting edge research on functional, porous materials for gas storage and separationCollaborative research resulted in publication of “Reticular Synthesis of Covalent Organic Borosilicate Frameworks,” which demonstrated the gas adsorption properties of this novel materialSynthesized organic and inorganic materials under inert atmospheres and high pressures using Schlenk lines and autoclavesCharacterized materials using x-ray diffraction, IR, UV-Vis, and H-NMR spectroscopyDiscussed and shared research ideas during laboratory group meetings Show less
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Research and Development Co-op
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Nov 2006 - Aug 2007
Formulated a commercially viable tin plating solution that improved lustre and contaminant tolerance Conducted electrodeposition of copper, nickel, and gold onto electronic components such as capacitor chips Analyzed metal layer thickness using x-ray fluorescence Participated in weekly R&D team meetings to discuss new trends and research Formulated a commercially viable tin plating solution that improved lustre and contaminant tolerance Conducted electrodeposition of copper, nickel, and gold onto electronic components such as capacitor chips Analyzed metal layer thickness using x-ray fluorescence Participated in weekly R&D team meetings to discuss new trends and research
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Undergraduate Researcher
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May 2005 - Oct 2006
Studied RNA degradation due to iron impurities found on the surface of quartz to determine potential mineral toxicity during mining and sand blast operations Explored hydroxyl radical generation by various asbestos samples using fluorescence spectroscopy Conducted experiments in a glove box under anoxic conditions to better understand how reactive oxygen species are generated in the absence of molecular oxygen Presented results during undergraduate seminars and poster presentations Show less
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Education
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2007 - 2009
University of California, Los Angeles
Master of Science (M.S.), Chemistry -
2002 - 2006
Stony Brook University
Bachelor of Science (B.S.), Chemistry
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