Summary
Overview
Work History
Education
Skills
THERAPETUIC AREA OF EXPERTISE
Timeline
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Chiagozie Uzoh

Maricopa,AZ

Summary

Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.

Overview

9
9
years of professional experience

Work History

Clinical Trial Manager

PPD
01.2021 - Current
  • Enhanced patient safety by meticulously monitoring clinical trial activities and promptly addressing any issues.
  • Contribute to preparation of clinical protocols, amendments, informed consent forms, study manuals and guides, electronic case report forms, and any other clinical research related documents.
  • Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
  • Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
  • Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
  • Mitigated risks in clinical trial process by proactively identifying potential issues and implementing corrective actions(CAPA).
  • Improved data quality in clinical trials by overseeing data management activities such as data cleaning, validation, and database lock procedures.
  • Contributed to protocol development, ensuring well-designed study that met research objectives while adhering to ethical standards and regulations.
  • Developed training materials for site staff to enhance their understanding of study protocol, resulting in improved adherence to requirements.
  • Spearheaded selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
  • Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Ensure timely response to queries and monitoring discrepancies.
  • Manage investigational product (IP) and non-IP study drug accountability and reconciliation process.

Senior Clinical Research Associate

PPD
10.2018 - 01.2021
  • Improved clinical trial efficiency by streamlining data collection and management processes.
  • Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
  • Reduced study timelines by effectively managing multiple concurrent clinical trials across various therapeutic areas.
  • Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
  • Optimized study startup times by proactively addressing potential bottlenecks and refining site selection criteria.
  • Increased accuracy of study data by implementing robust quality control measures during data review and analysis phases.
  • Supported regulatory submissions with comprehensive documentation preparation, leading to successful approval of investigational products.
  • Developed strong relationships with investigators and site staff, fostering culture of trust and open communication throughout study duration.

Clinical Research Associate

PPD
06.2015 - 10.2018
  • Improved patient enrollment by developing and implementing effective recruitment strategies.
  • Conducted Source Document Review of appropriate site source documents and medical records.
  • Ensured required Essential Documents are filed in Study Master File, maintain device and regulatory document tracking systems.
  • Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
  • Collaborated with cross-functional teams to successfully meet project timelines and deliverables.
  • Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
  • Contributed to development of study documents, including informed consent forms and case report forms.
  • Maintained comprehensive knowledge of applicable regulations and guidelines, ensuring full compliance throughout all stages of clinical trials.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.

Education

Bachelor of Science - Public Health

University of North Carolina At Greensboro
Greensboro, NC

Skills

  • Protocol development
  • Audit preparation
  • Document Review
  • Training and mentoring
  • Site Selection
  • Clinical Trial Oversight
  • Clinical Data Management
  • GCP Knowledge
  • Standard Operating Procedures
  • Site monitoring
  • Research SOPs understanding
  • Attention to Detail

THERAPETUIC AREA OF EXPERTISE

INFECTIOUS DISEASES: Influenza, HIV, COVID-19

MEDICAL DEVICES: Ventilators, Catheters, Hemodialysis Machine

ONCOLOGY: Breast Cancer, Solid Tumor

Timeline

Clinical Trial Manager

PPD
01.2021 - Current

Senior Clinical Research Associate

PPD
10.2018 - 01.2021

Clinical Research Associate

PPD
06.2015 - 10.2018

Bachelor of Science - Public Health

University of North Carolina At Greensboro

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Chiagozie Uzoh