Summary
Overview
Work History
Education
Skills
THERAPEUTIC AREAS
Timeline
Generic

CHARLES UFUOMA EDEKI

Katy,Texas

Summary

Clinical Research Professional with more than 5 years of experience managing phases I-III clinical trials, I possess a comprehensive understanding of ICH and GCP regulations. My skills in site management are exceptional, and I excel in organizing and planning, with excellent time management abilities. I am meticulous in my attention to detail and committed to delivering high-quality work. My ability to work both independently and as part of a team is excellent, and I am proficient in standard operating procedures. I can thrive in a fast-paced environment while ensuring compliance with regulatory requirements and meeting deadlines.

Overview

9
9
years of professional experience

Work History

Senior Clinical Research Associate

LabCorp
03.2020 - Current
  • • Conducted site management and monitoring for sponsored clinical studies phases I-III in oncology, dermatology, immunology, ophthalmology, nephrology, endocrinology.

    • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies using keywords and techniques from the study design.

    • Performed on-site pre-study/qualification, initiation, routine, and close-out visits, while ensuring compliance with regulatory and ICH/GCP guidelines.

    • Educated and trained site and study staff in management of sponsored studies and collected and processed regulatory documentation for investigational studies in compliance with required guidelines.

    • Assisted in protocol, Informed Consent, and CRF design and review.

    • Developed and demonstrated understanding of and applied therapeutic area knowledge.

    • Resolved issues related to trial monitoring and management with guidance from Project Manager and served as primary point of contact for all assigned sites.

    • Evaluated study questionnaires to review and suggest changes.
  • Maintained research data, patient fields, regulatory binders, and study databases for organization and quick reference.

    • Collected data and followed research protocols, operations manuals, and case report form requirements.

    Coordinated investigators by reviewing and maintaining records of qualification for research.
    Managed documentation, including clinical research data worksheets, shared drive and clinical research files.
    Maintained research data, patient fields, regulatory binders and study databases for organization and quick reference.
    Continuously monitored active studies to verify compliance with facility's protocols and regulatory standards, helping to protect personnel from legal issues.

CLINICAL RESEARCH ASSOCIATE II

AbbVie
01.2018 - 02.2020
  • • Managed on-site and remote study monitoring, ensuring compliance with company/client SOPs and Clinical Monitoring Plan, and maintaining up-to-date knowledge of GCP and FDA guidance.

    • Assisted in clinical study planning and management, including drafting protocol-specific manuals, plans, and documents as needed, identifying and recruiting potential investigators and study sites, and verifying site qualifications and capabilities to conduct clinical studies.

    • Worked closely with Clinical Trial Manager and In-House CRAs to ensure the accuracy and completeness of Trial Master File throughout the lifecycle of the project.

    • Conducted site training for assigned clinical trials, as well as site audits and site quality management activities as needed.

    • Maintained research data, patient fields, regulatory binders, and study databases for organization and quick reference.

    • Documented adverse events and data covering side effects, conferring with investigators about reports and working with oversight agencies on management of incidents.

    • Demonstrated a deep understanding of assigned therapeutic areas and kept up to date with current developments in the field.

Clinical Research Associate

Parexe I
02.2016 - 01.2018
  • Ensured compliance with local and federal regulations by monitoring the safety of human subjects and overseeing consent procedures.

    • Followed protocols and SOP requirements for drug storage.

    • Conducted on-site and remote study monitoring and site management, including initiation, interim monitoring, and close-out visits.

    • Maintained positive relationships with internal and external project stakeholders, including clients, team members, PIs, and study coordinators.

    • Assisted in identifying and recruiting potential investigators and study sites, verifying site qualifications and capabilities to conduct clinical studies.

    • Ensured that Trial Master File was accurate and complete throughout the project lifecycle.

    • Prepared and conducted site training for assigned clinical trials.

    • Assisted with site audits and quality management activities as needed.

    • Managed clinical study activities for over 12 sites by setting up and disbanded trial study centers.

Clinical Research Coordinator

UT Health
01.2014 - 02.2016
  • Facilitated daily trial activities and maintained compliance with research protocols, working with principal investigators and sponsors.

    • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Monitored health and responses during clinical research studies in conjunction with physicians and scientists, performing physical assessments and vital signs, administering treatments and/or therapies, and assuring research participant safety.

    • Performed quality control reviews and developed reports demonstrating findings.

    • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.

    • Participated in Institutional Review Board (IRB) submissions, identification, and enrollment of research study participants.

    • Adjusted care plans of patients to suit individual requirements, maintained data, and followed-up on patients under care.

    • Maintained regulatory forms, source documentation, and case reports documentation in accordance with established protocols.

    • Implemented trials in accordance with study timelines and budgets, participating in initiation visits and investigator meetings.

Education

Bachelor of Science - Physics

Delta State University
Delta State
11.2009

Skills

Ability to build effective relationships with site personnel, CRO staff, and colleagues

Strong organizational skills

Excellent attention to detail and ability to maintain detailed and accurate records

Knowledge of statistical data collection, validation, editing, and analysis techniques

Superior problem-solving, deductive reasoning, and decision-making skills

Good time management and ability to prioritize tasks and accomplish set goals efficiently

Ability to work independently Study monitoring Monitoring Visits Site Investigations

THERAPEUTIC AREAS

• Oncology: Leukemia, Pancreatic Cancer, Solid Tumor, and Soft Tissue Sarcoma

• Dermatology: Atopic dermatitis, Actinic keratosis, and Contact dermatitis

• Immunology: Autoimmune diseases, Allergies, Immunodeficiency disorders, Inflammatory diseases

. • Ophthalmology: Cataract, Proptosis, Conjunctivitis, and Glaucoma

• Nephrology: Glomerulonephritis, Urinary tract infections, and Polycystic kidney disease

• Endocrinology: Addison's disease, Cushing's disease, and Hyperthyroidism

• Rare Disease: Schnitzler Syndrome.

Timeline

Senior Clinical Research Associate

LabCorp
03.2020 - Current

CLINICAL RESEARCH ASSOCIATE II

AbbVie
01.2018 - 02.2020

Clinical Research Associate

Parexe I
02.2016 - 01.2018

Clinical Research Coordinator

UT Health
01.2014 - 02.2016

Bachelor of Science - Physics

Delta State University

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CHARLES UFUOMA EDEKI