Dieunese Antoine
MURFREESBORO,TN
Summary
Dedicated and detail-oriented Clinical Research professional managing data, and ensuring compliance with regulatory standards. Proven track record in data analysis, patient recruitment, regulatory submissions, etc. Strong background in the medical field. Adept at collaborating with multidisciplinary teams to achieve research goals and improve patient outcomes.
Overview
1
1
Certification
Work History
Clinical Research Training
Clinical Research Fastrack
Nashville, TN
07.2024 - Current
CH GCP E6 R(2)
• FDA Regulations 21CFR 11, 50, 54,56 and the Common Rule 45CFR46
• Data Management
• Informed Consent Process
• Clinical Trial Operations from feasibility through close-out.
• GDP following ALCOA-C principles
• Identification and reporting of AEs and SAEs
• Quality Assurance, Monitoring, and Query Resolution
• Comprehension and Execution of Clinical Trial Protocols
• Maintaining regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs and other Investigator Site File (ISF) documents.
Education
Good Clinical Practice - ICH E6 (R2)| Dangerous Goods Training -
Clinical Research Fast Track
Skills
- Medical Terminology
● Monitoring
● Good Laboratory Practice
● Microsoft Excel
● Scientific Software
● Patient Tracking Software
Languages
Spanish
Full Professional
french
Native/ Bilingual
Certification
- IMg
- ultrasound diagnostic
References
References available upon request.
Timeline
Clinical Research Training
Clinical Research Fastrack
07.2024 - Current
Good Clinical Practice - ICH E6 (R2)| Dangerous Goods Training -
Clinical Research Fast Track
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