Desewa Nade
Mental Health Advocate
- Role
- Clinical Research Trainee at Clinical Research Fastrack
- Location
- Washington, DC, US
- LinkedIn followers
- 500 followers
About Desewa Nade
Multidisciplinary analyst with hands-on experience in healthcare IT, financial…
Experience
Clinical Research Trainee
Nov 2022 — Present
Trained by leading clinical research professionals on components such as:ICH-GCP Guidelines & Protecting the Rights of the Patient.FDA Regulations - 21CFR11, 21CFR50, 21CFR54, 21CFR56, etc.Regulatory Affairs - Regulatory binder, form 1572, etcDissection of a protocol - Sections, budgeting, flow chart, etc.GDP - ALCOA-C, regulations of GDP, etc.Data Management Systems - IP compliance, storage, handling, IWRS, etc.AEs and Protocol Deviations - Reporting and assessing SAEs and AEs, Protocol deviations and violations, etcMonitoring, Quality Assurance and Inspections - FDA form 483, Audits and Inspections, etc.Investigator Responsibilities - PI oversight, FDA form 1572Clinical Trial Operations - Feasibility, SIVs, IMs, etc.Informed Consent Process - Regulation and Guidance, ICF, Informed consent discussion, assent, etc. Clinical Research acronyms - ICF, IRB, CRF, IND, IP, I/E, SOPs, etc.
Education
Bowie State University
Masters
Teesside University
Master of Science - MS
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