Seasoned Regulatory Affairs Officer with over 5 years in developing effective processes and executing regulatory affairs initiatives for Human Medicine and Veterinary Medicine industries. Improved processes and assisted product development in meeting regulatory requirements. Maintained and followed up on records of regulatory information and submissions.
•Efficiently managed the documentation and dispensing of Rx as well as IV medications and optimized process for ordering fluid supplies through EMR.
•Ensured properly separated pathology specimens manually under a hooded area, complying with HIPAA and OSHA regulations.
•Maintained clear and professional communication with both clinical and administrative team members.
•Contributed to drafting and publication and issuing various technical documentation.
Experienced healthcare and research professional with 5 years’ proficiency and background central to clinical patient care, biomedical research, veterinary nursing, chemistry laboratory diagnostics and OSHA protocol management Certified OSHA compliance trainer
CITI PROGRAM:
-GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Course.
Issued Date: April 2024
Expiry Date: April 2025
Credential ID: 62301107
-GCP – Social and Behavioral Research Best Practices for Clinical Research
-Research Study Design (RSD)
-Bioethics
-Biomed Comprehensive
-Clinical Research: An Introduction
-IACUC Community Members
-Reducing Pain and Distress in Lab Mice and Rats
-Working With Amphibians in Research Settings
- Working With Fish in Research Settings
-Working With Zebra Fish (Danio Rerio) in Research Settings
-Animal Biosafety
-Basic Introduction to Biosafety
-Covid-19: Back to Campus (2020-2023)
-COVID-19: Insights for Higher Ed Leaders
-Dual Use Research of Concern (DURC)
- Emergency and Incident Response to Biohazard Spills and Releases
-Group 1: Physical Sciences
-Group 1: Researchers (ACU) and (COI)
-Group 1: Researchers (Essentials for IACUC Members)
-Researchers (IPS)
-Group 2: Animal Technicians (Essentials for IACUC Members) and (ACU)
-Group 2: Research Administrators and Staff (HSR) and (ACU)
-Group 3: “ “ Essentials for the IACUC Staff
-IACUC Members and IACUC Staff (ACU)
-Group 5: IACUC Community Members (Essential for the IACUC Members)
-Hazard Communication
-Initial Biosafety Training
-Mental Health for Higher Education and Healthcare
-NIH Recombinant DNA Guidelines
-OSHA Bloodborne Pathogens
-Participating in Vaccine Research
-PPE
-Public Health Research
-Remote Contact Tracing
-Shipping and Transport of Regulated Biological Materials
-What You Need to Know About COVID-19 Vaccine
MAYO CLINIC:
-Blood Cultures
Issue Date: March 2024
Expiry Date: March 2026
Credential ID: 058/048/23
-Challenging Patient Encounters
-Complement Testing in the Diagnosis and Management of Thrombotic Microangiopathy
-IATA
-Transporting of Dangerous Goods
-Keys to Leadership in Extraordinarily Difficult Times: Part 2
-Phlebotomy Lab Operations
-The Evolution of Phlebotomy
-Race and Estimated GFR: Confounding of Social and Biological Variables
-Transfusion Decisions
OSHA:
-AH: Animal Health
-AH: Animal Health Fillable Forms Instructions
Continued Certifications:
-Advanced Clinical Research Assistant
-Basic Life Support
-CPR/ AED/ First Aid