Lisa Sharp MBA, CCRP
Clinical Lead at Lexitas Pharma Services, Inc.- Claim this Profile
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German -
Topline Score
Bio
Credentials
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Stanford Manager Academy Graduate
Stanford University Graduate School of BusinessJun, 2018- Nov, 2024 -
Silver U
University of Nebraska Medical CenterNov, 2015- Nov, 2024 -
C.O.A, CCRP
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ICH/GCP
CITI Program
Experience
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Lexitas Pharma Services
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United States
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Research Services
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100 - 200 Employee
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Clinical Lead
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Mar 2022 - Present
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Research
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Jan 2022 - Mar 2022
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TG Therapeutics, Inc.
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United States
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Biotechnology Research
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200 - 300 Employee
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Clinical Operations
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Oct 2021 - Jan 2022
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Duke University Health System
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Hospitals and Health Care
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700 & Above Employee
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Research Program Manager
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Apr 2021 - Aug 2021
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Stanford University School of Medicine
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United States
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Higher Education
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700 & Above Employee
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Clinical Research Supervisor
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Mar 2017 - Jun 2021
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University of Nebraska Medical Center
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Higher Education
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700 & Above Employee
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Clinical Research Manager
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Jun 2013 - Mar 2017
Oversee the logistics, management and execution of clinical studies and research programs. Negotiating budgets and some contract terms for conducting studies and research trials. Manage clinical trial budgets, payment process, both payables and rec Develop plans, references and timelines for clinical study protocols. Regulatory skills include IRB submissions and maintaining, consent form creation within ICH/GCP and CFR guidelines. Computer skills include but are not limited to MS Excel, Power Point, MS Word, and Outlook. Database searches and Internet use. EPR, Groupwise, Host Interface Portal Outpatient scheduling, DARC online submissions, Study Trax data management, Advantage EDC, Medidata Rave, Basic knowledge of CPT, ICD-10, E/M coding including the elements of CC/HPI for coding levels. Train Research associates on protocols, trial plans, monitoring tasks and research process. Ensure studies adhere to guidelines and regulations set by federal, state and local health departments. Prepare regulatory documents and maintain records for clinical studies Post-graduate Training includes Finance, Marketing, Human Resources, Organizational Management and Leadership. Also responsible for creating and maintaining the group NCT registrations on ClinicalTrials.gov Ophthalmic skills include but are not limited to: Refraction (Phoropter, Manual, Automated and Trial Frame/loose lens), tonometry (Goldmann applanation and tonopen), visual fields (confrontation and Humphrey automated) EOM’s and motility, Heidelberg Spectralis Retinal Tomography, Cirrus HD OCT, Optos Wide angle Photography, GDX, Optical Coherence Tomography, Fundus Photography, Pachymetry, A-scan. Nidek MP-1 microperimetry, DIRC Certified. Ellex scleral limbal Ultrasound training 7/2013
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Johns Hopkins Medicine
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United States
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Coordinator
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Sep 2006 - Jun 2012
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Education
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Cleary University
MBA, Business Administration and Management, General