VANESSA Oduonye
Houston
Summary
Experienced Clinical Research Associate with 6+ years managing Phases I–IV trials, including oncology. Skilled in ICH-GCP/FDA compliance, optimizing operations, leading remote teams, and driving process improvements. Proven track record of delivering high-quality results on time and within budget.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Training
U.S. Navy Reserve
03.2025 - 08.2025
- Completed a five-month training commitment with the U.S. Navy Reserve.
Clinical Research Associate II
Syneos Health
Houston
09.2023 - 02.2025
- Managed oncology clinical trials across multiple phases, ensuring strict adherence to protocols and regulatory guidelines (ICH-GCP, FDA).
- Coordinated remote site operations, fostering seamless communication among study teams, and addressing issues swiftly through virtual collaboration tools, improving overall study efficiency.
- Led process improvements to streamline clinical trial management and enhancing data collection efficiency.
- Developed monitoring plans tailored to study needs, enhancing site performance and protocol compliance.
- Mentored and trained new CRAs, boosting team productivity and ensuring a high level of protocol adherence across all clinical trials.
- Resolved site deviations with creative solutions, improving data integrity and trial quality, resulting in zero major findings during regulatory inspections.
- Conducted on-site and remote monitoring visits (PSSVs, SIVs, IMVs, COVs), ensuring data compliance, TMF readiness and audit compliance always.
- Optimized patient recruitment strategies, improving enrollment rates by 20%, and reducing the time to enrollment by 30% through targeted outreach.
Clinical Research Associate I
Syneos Health
Houston
10.2021 - 09.2023
- Managed oncology clinical trial progress, ensuring that IRB approvals, patient recruitment, and site evaluations met deadlines, contributing to a timely study initiation.
- Collaborated remotely with global study teams, utilizing eClinical tools to ensure seamless communication and efficient data management across all trial sites.
- Implemented process improvements in patient tracking and data management, reducing discrepancies by 25% and enhancing trial outcomes.
- Collaborated with cross-functional teams to achieve early final base lock for key studies, contributing to improved study timelines and successful trial outcomes.
- Initiated process changes, introducing innovative tracking systems that reduced patient enrollment time by 15% and boosted site efficiency.
- Led site activation efforts, ensuring compliance with regulatory requirements and completing site startup activities for 50+ sites across multiple trials.
Clinical Research Associate I
MedPace
Urbana
08.2019 - 09.2021
- Conducted site visits for clinical trials, ensuring protocol compliance and resolving issues swiftly, improving site performance and overall study timelines.
- Developed new data management strategies that reduced data discrepancies and improved protocol adherence, leading to more efficient trial progression.
- Fostered strong relationships with site staff, providing guidance on protocol adherence, improving patient recruitment, and enhancing site compliance rates.
- Collaborated with remote teams to manage clinical data and ensure all regulatory requirements were met, achieving compliance during audits.
- Streamlined clinical supply management for the trial, ensuring that study drugs and materials were handled efficiently and in compliance with safety protocols.
Clinical Research Coordinator
MD Anderson
Houston
07.2018 - 08.2019
- Recruited diverse patient populations, improving trial participation rates and ensuring compliance with study protocols.
- Maintained comprehensive study documentation and regulatory files, ensuring audit readiness and adherence to regulatory standards.
- Implemented safety protocols, promptly addressing health concerns and ensuring that adverse events were reported in compliance with FDA guidelines.
- Trained site staff on clinical trial protocols, enhancing team competency and improving patient recruitment and informed consent processes.
Education
Bachelor of Science - Biology
Federal University of Technology
Minna, NigeriaMASTER OF SCIENCE - BIOTECHNOLOGY
Federal University of Technology
Minna, NigeriaSkills
- Clinical trial management
- ICH-GCP and FDA compliance
- Remote team leadership
- Process improvement
- Data management systems
- Risk management and quality assurance
- Cross-functional coordination
- Change management
- Protocol development and regulatory compliance
- Patient recruitment strategies
- Written and verbal communication
- Time management skills
- Analytical and problem-solving skills
Certification
- GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus) Course
- Google Data Analytics Specialization
Therapeutic Areas
· Oncology: Solid Tumor (Adult), Prostrate Cancer, Breast Cancer, Lung Cancer, Leukemia and Ovarian Cancer.
· Dermatology: Genital Psoriasis, Acne and Eczema.
· Vaccine: HPV (Human Papillomavirus) and COVID-19.
SYSTEM EXPERIENCE
• eTMF: Veeva Vault, ADaM.
• EDC: Medidata Rave, Inform, Trialmaster.
• CTMS: Siebel, Impact.
• Imaging: Icon, Calyx.
• IWRS: Suvoda, Endpoint, Signant Health.
• ePRO: Trialmax, Clario.
• Data Analysis and Visualization Tools: Power BI, Control Tower, Tableau, R Programming.
Timeline
Training
U.S. Navy Reserve
03.2025 - 08.2025
Clinical Research Associate II
Syneos Health
09.2023 - 02.2025
Clinical Research Associate I
Syneos Health
10.2021 - 09.2023
Clinical Research Associate I
MedPace
08.2019 - 09.2021
Clinical Research Coordinator
MD Anderson
07.2018 - 08.2019
Bachelor of Science - Biology
Federal University of Technology
MASTER OF SCIENCE - BIOTECHNOLOGY
Federal University of Technology
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