Charlene Ekenemchukwu Nwajei
Dallas-Fort Worth Metroplex
Summary
Results-driven Clinical Research professional with extensive training in ICH GCP and FDA Regulations and 3+ years of experience of medical experience, dedicated to promoting excellence in clinical research through precision, subject safety, and patient advocacy. Expertise in data management, patient care, accurate medical documentation, and protocol compliance/management. Proficient in Microsoft Office, EMR, EHR, and eClinicalWorks, etc.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Clinical Research Trainee
Clinical Research Fastrack
Remote
01.2025 - 03.2025
- Participated in an 80 Hours of Clinical Research Training covering Core Competencies including:
• ICH GCP E6 R (2) and Patient Safety
• FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46
• Data Management in EDC systems and Informed Consent Process
• Clinical Trial Operations from feasibility through close-out
• GDP following ALCOA-C principles and IRB Protocols and materials
• Identification and reporting of Adverse and Serious Adverse Events
• Quality Assurance, Monitoring, and Query Resolution and study-monitoring visits
• Comprehension and Execution of Clinical Trial Protocols
• Maintaining a regulatory binder and housing essential documents including 1572, DOA, Training Logs, Case Report Forms, and other Investigator Site File (ISF) documents
Travel Medical Assistant
North Texas OBGYN Associates
Lewisville & Flower Mound
02.2024 - 08.2024
- Partnered with healthcare providers in various procedures such as pap smears, colposcopies, pelvic exams, routine lab testing, while following strict medical protocols and standards
- Administered injections including Rhogam, Tdap, and Gardasil etc., while ensuring patient compliance and safety
- Streamlined laboratory requisitions processes to multiple testing facilities such as Myriad, Natera, NexGen, CPL, and Path Advantage
- Executed precise documentation on patient’s vitals, conditions, use of medication, and their family history in Electronic Medical Systems (EMR) and Electronic Health Records (HER)
- Clinical hours gained: 782+ hours
Lead Medical Assistant/Tech
Alliance Medical Partners/Be Well Primary Care
Denton
09.2022 - 10.2023
- Conducted vital scan ANS tests, ECG analysis, vital scan SUDO tests, immunotherapy shots, and allergy tests on patients
- Recruited patients and verified patient’s insurance for eligibility based on questionnaires and approved/accessible medical records
- Maintained accurate patient data in eClinicalWorks database and trained new coworkers to ensure smooth clinical operations
- Clinical hours gained: 752+ hours
Study Abroad Student Doctor (Undergrade Shadowing)
Atlantis
Praia
07.2023 - 08.2023
- Analyzed diverse medical practices through intensive shadowing rotations and live surgeries to gain exposure to specialized surgical techniques and patient management strategies
- The medical fields I shadowed with were Internal Medicine, OB/GYN, Cardiovascular surgery, Orthopedic surgery, Pediatrics, and Oncology
- Shadowing hours gained: 60+ hours
Data Entry Clerk
Memorial Herman's Alief Geriatrics Associates Clinic
Houston
07.2017 - 08.2017
- Entered precise client data into Patient Fusion for efficient coworker access and smooth clinical operations
- Clinical hours gained: 320 hours
Education
Bachelor of Science - Kinesiology And Biology (Pre-Med)
University of North Texas
Denton Texas12.2024
Skills
- Vaccine injections
- Immunotherapy injections
- Allergy testing
- Urine & culture analysis
- ECG analysis
- Blood pressure readings
- Clinical trial protocols
- Microsoft Office
- EMR
- EHR
- All Scripts
- EClinicalWorks
- EDC systems
- Patient Fusion
- Data entry/collection
- FDA regulations
- ICH-GCP
- ALCOA-C principles
- AE/SAE reporting
- Recruitment
- Interaction
- Informed consent process
- Patient education
- Detailed-oriented
- Adaptable
- Dependable
- Strong communication
- Organization
- Determination
- Regulatory compliance
- Patient care
- Team collaboration
- Quality assurance
- Critical thinking
- Data management
Certification
- Good Clinical Practice - ICH E6 (R2), Clinical Research Fastrack, 01/01/25, TransCelerate Approved
- BLS/CPR/AED Certification, American Red Cross, 12/01/24, 01OR8SF
Timeline
Clinical Research Trainee
Clinical Research Fastrack
01.2025 - 03.2025
Travel Medical Assistant
North Texas OBGYN Associates
02.2024 - 08.2024
Study Abroad Student Doctor (Undergrade Shadowing)
Atlantis
07.2023 - 08.2023
Lead Medical Assistant/Tech
Alliance Medical Partners/Be Well Primary Care
09.2022 - 10.2023
Data Entry Clerk
Memorial Herman's Alief Geriatrics Associates Clinic
07.2017 - 08.2017
Bachelor of Science - Kinesiology And Biology (Pre-Med)
University of North Texas
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