Ikenna Okafor
Clinical Research Professional @Clinical Research Fastrack
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WORK HISTORY
Clinical Research Professional @Clinical Research Fastrack
ICH GCP E6 R2• Informed Consent Process• Comprehension and Execution of Clinical Trial Protocols• FDA Regulations 21 CRF Parts 11, 50, 54, 56• Monitoring, Quality Assurance, and Inspections• Identification and reporting of AEs and SAEs• Protecting Patient\'s Rights and Safety• Maintaining a regulatory binder, housing essential documents including but not limited to 1572, Source documents, DOA, Training Logs, ICF, SAE forms, Financial disclosures, Site Visit Logs, Standard Operating Procedures (SOP), and Correspondences ICH GCP E6 R2 Informed Consent Process Comprehension and Execution of Clinical Trial Protocols FDA Regulations 21 CRF Parts 11, 50, 54, 56 Monitoring, Quality Assurance, and Inspections Identification and reporting of AEs and SAEs Protecting Patient\'s Rights and Safety • Maintaining a regulatory binder, housing essential documents including but not limited to 1572, Source documents, DOA, Training Logs, ICF, SAE forms, financial disclosures, Site Visit Logs, Standard Operating Procedures (SOP), and Correspondences
EDUCATION
Middle Tennessee State University (MTSU)
Bachelor of Applied Science (BASc), Chemistry
Kennesaw State University
Master's degree, International Policy Management
Clinical Research Fastrack
Clinical Research Professional Training
ABOUT IKENNA OKAFOR
With over a decade of hands-on experience in analytical instrumentation, method validation, and troubleshooting, I bring a unique blend of scientific expertise and technical acumen that aligns perfectly with this role. As an Analytical Chemist who has worked extensively with complex lab instruments such as ICP-OES and ICP-MS, I am passionate about applying my skills in a field-based, client-focused environment.
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