プロフィール詳細

プロジェクトを作成

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Jessica B.に依頼

United States

Global Project Leader in CNS | 10+ years of experience in clinical research | ACRP Certified

プロフィール概要

Global Project Leader in Psychiatry & Neurology. Former Research Scientist in Psychiatry. Experienced ACRP Certified Clinical Research Coordinator with over 10 years of clinical research experience in Psychiatry/Neuroscience. A demonstrated history of successful clinical research project management; project management experience from CRO, Sponsor and Site perspectives; federally and industry funded phases II-IV. Skilled in Project Management, Regulatory Compliance, ICH-GCP compliance, Data Management, Quality Assurance, Clinical Monitoring, Start-up and Clinical Research Oversight.

専門分野

• ★ Clinical Trial Documentation
• ★ Medical Writing
• ★ Project Management
• ☆ Drug Development
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Counseling & Mental Health Support
• ☆ Drug Addiction Treatment
• ☆ Substance Abuse
• ☆ Anxiety Disorders
• ☆ Depression
• ☆ Counselor Education
• ☆ Psychiatry
• ☆ Child & Adolescent Counseling
• ☆ Neuropsychiatry
• ☆ Addiction Psychiatry
• ☆ Psychoactive Drugs
• ☆ Feasibility Studies
• ☆ Literature Search
• ☆ Regulatory Writing
• ☆ NDA/BLA Applications
• ☆ Clinical Trial Protocol Writing
• ☆ Research Summaries & Abstracts
• ☆ Investigational New Drug (IND) Application Writing
• ☆ Literature Review
• ☆ Systematic Literature Review
• ☆ Scientific Proofreading & Editing
• ☆ Proofreading & Editing
• ☆ Audio Transcription
• ☆ Risk Management

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Audio Transcription, General Proofreading & Editing

Research User Research, Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting, Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Quality Assurance & Control (QA/QC), Product Compliance

職務経験

Global Project Leader

IQVIA

7月 2021 - 現在

Clinical Research Scientist

University of Texas Southwestern (UTSW). Dallas. USA

3月 2021 - 7月 2021

Clinical Trials Operations Lead

University of Texas Southwestern (UTSW). Dallas. USA

10月 2019 - 3月 2021

Clinical Research Coordinator

University of Texas Southwestern (UTSW). Dallas. USA

10月 2016 - 10月 2019

学歴

Master of Science in Clinical Mental Health Counseling

University of North Texas at Dallas

1月 2016 - 8月 2019

Bachelors of Science in Neuroscience

UT Dallas

8月 2011 - 5月 2014

認定資格

• Certified Clinical Research Coordinator

  Academy of Clinical Research Professionals

  1月 2021 - 現在

出版物

JOURNAL ARTICLE

Ketcherside, A., Jeon-Slaughter, H., Baine, J.L., Filbey, F.M.(2016). Discriminability of personality profiles in isolated and Co-morbid marijuana and nicotine users . Psychiatry Research. 238. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 356-362.

Ketcherside, A., Baine, J., Filbey, F.(2016). Sex Effects of Marijuana on Brain Structure and Function . Current Addiction Reports. 3. (3). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 323-331.

Filbey, F.M., Dunlop, J., Ketcherside, A., Baine, J., Rhinehardt, T., Kuhn, B., DeWitt, S., Alvi, T.(2016). fMRI study of neural sensitization to hedonic stimuli in long-term, daily cannabis users . Human Brain Mapping. 37. (10). Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 3431-3443.