Uzoma Onukwubiri
Washington,DC
Summary
Experience in clinical trial management, clinical regulatory guidelines and feasibility assessment. Excellent at handling multiple tasks and picking up new processes quickly. Skilled in conducting site visits, ensuring protocol compliance, and maintaining high-quality data collection. Committed to patient safety and excellence in clinical research, with a strong background in Good Clinical Practice (GCP) and regulatory requirements.
Overview
13
13
years of professional experience
Work History
Clinical Research Project Manager
Association of Black Cardiologists
12.2019 - Current
- Led the preparation and submission of proper documentations to Regulatory Authorities
- Ensured compliance with study protocols, consent forms, confidentiality agreements and PI participation agreements
- Performed site selection, initiation, monitoring and close-out visits
- Managed research awards and disbursed over $1,000,000 in funding to recipients
- Initiated the formation of a Clinical Research Network and hosted Local Study Team meetings
- Improved data collection processes by optimizing various aspects of the process
- Managed study coordinators in multiple sites, ensuring protocols adherence and timely data submission
- Facilitated collaboration between stakeholders (PIs) in the organization, CROs and pharmaceutical companies
- Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-ups
- Worked with CROs & SMOs to assess site feasibility and prepare for successful study recruitment
- Supported Senior Clinical Trial Manager in various initiatives
- Coordinated the filing of documents in electronic Trial Master Files (eTMF) and supported close-out activities in the eTMF system
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution
- Participates & provides inputs on site selection and validation activities.
- Facilitated clear communication between cross-functional teams to ensure alignment on project goals and expectations throughout the study life cycle.
- Played an instrumental role in expediting the entire review process through timely identification and resolution of data discrepancies.
Clinical Data Manager
National Cancer Institute, NCI
09.2016 - 12.2019
- Established new documentation review process to ensure GCP regulatory compliance and reduce delays associated with IRB compliance by 30%
- Mentored new clinical staff
- Managed phase 1-4 studies as a data specialist and 5 protocols as an in-house clinical research associate
- Conducted internal audits for regulatory compliance and data accuracy verification
- Validated and reconciled data from multi-institutional study sites
- Tested data entry screens and CRF designs to ensure compliance with the protocol and guidelines
- Identified database design problems and worked with programmers to implement changes for accurate data collection
- Performed clinical data collection/abstraction from EHR to electronic data systems
- Reported SAEs to sponsors and resolved data queries from sponsors.
Research Assistant
University of Pittsburgh School of Dental Medicine
09.2011 - 04.2012
- Developed and implemented recruitment plans and strategies that yielded over 20% growth in study recruitment
- Collaborated with a multidisciplinary team to develop Standard Operating Procedures, support protocol implementation and quality data collection
- Reported on a regular basis to the Principal Investigator on study progress
- Analyzed quantitative and qualitative data on a longitudinal study, sorted out discrepancies and identified areas of improvement for the next phase of the study.
- Enhanced research quality by meticulously collecting and analyzing data from various sources.
- Managed laboratory equipment and resources, ensuring proper maintenance and optimal functionality.
Education
Masters of Public Health -
University of Pittsburgh Graduate School of Public Health
Pittsburgh, PA04.2012
Bachelor of Science in Life Sciences -
Pennsylvania State University
University Park, PA05.2009
Skills
- Quality Control
- Strategic Planning
- Document Management
- Contract Development
- Cardiology and Oncology Studies
- Stakeholder Engagement
- Patient Recruitment
- Public Health Cert
Affiliations
- American Public Health Association (APHA)
- Society of Clinical Research Association (SOCRA)
- Association of Clinical Research Professionals (ACRP)
Technical Skills
MS Office 365 Suite | STATA | Medidata Rave | RedCap | Open Clinical
Publications
- Local Brain Drain? Correlates of Nursing Shortages in Rural Zambia, Owen S., Leila R., Megan G., Alycia P., Patty S., Onukwubiri U., 2009-01-01, American Public Health Association, https://apha.confex.com/apha/137am/webprogram/Paper206419.html
- Cediranib Phase-II study in children with metastatic alveolar soft-part sarcoma (ASPS), Cohen JW, Widemann BC, Derdak J, 2019-01-01, Pediatr Blood Cancer, https://doi.org/10.1002/pbc.27987 (Clinical Data Specialist)
- Phase I Trial of Bortezomib and Clofarabine in Refractory MDS, lymphomas, or solid tumors, Khan S, Takebe N, https://nci frederick.cancer.gov/Khan-MDS.pdf (Clinical Data Specialist)
Timeline
Clinical Research Project Manager
Association of Black Cardiologists
12.2019 - Current
Clinical Data Manager
National Cancer Institute, NCI
09.2016 - 12.2019
Research Assistant
University of Pittsburgh School of Dental Medicine
09.2011 - 04.2012
Masters of Public Health -
University of Pittsburgh Graduate School of Public Health
Bachelor of Science in Life Sciences -
Pennsylvania State University
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