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Chinweuju Obi

@chinweuju

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Experienced Clinical Research Associate dedicated to advancing medical research.

United States

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What I'm looking for

I am looking for a role that fosters collaboration, innovation, and growth in clinical research.

I am a Clinical Research Associate with over a decade of experience in managing and coordinating clinical trials. My proven track record includes ensuring strict protocol adherence, meeting FDA guidelines, and achieving study objectives within budget and timeline constraints. I excel in effectively communicating with study sponsors, primary investigators, and multidisciplinary teams, which has been crucial in promoting patient safety and compliance.

Throughout my career, I have developed a strong proficiency in coordinating trial participants, assessing patient eligibility, and monitoring patient biometrics. My role at PPD has allowed me to perform site qualification and pre-trial assessments, manage off-site activities, and ensure compliance with Standard Operating Procedures and ICH GCP guidelines. I am dedicated to contributing to the advancement of medical research while maintaining a focus on patient safety and regulatory compliance.

Experience

Work history, roles, and key accomplishments

Current

Senior Clinical Research Associate

Current

PPD

Aug 2022 - Present (2 years 11 months)

Performed site qualification and pre-trial assessment visits, ensuring selected sites met protocol and timeline requirements. Managed off-site activities and independently monitored study processes in compliance with SOPs, ICH GCP guidelines, and regulations. Communicated with investigators and site staff across multiple studies to ensure smooth operations.

Regulatory Compliance Time Management

Clinical Research Associate I

PPD

Jul 2020 - Jul 2022 (2 years)

Identified, initiated, monitored, and closed out clinical investigative sites, maintaining study and site documents from initiation through archival. Ensured timely follow-up of site issues and action items, entering site visits and reports into the Clinical Trial Management System (CTMS). Monitored Case Report Forms (CRF/eCRF) for data quality and assisted sites with Electronic Data Capture (EDC)

Clinical Site Management Regulatory Compliance Time Management

Clinical Research Coordinator

MD Anderson

Sep 2018 - Jul 2020 (1 year 10 months)

Managed all aspects of clinical trials, ensuring strict adherence to protocols, FDA guidelines, study budgets, and timelines. Communicated with study sponsors and primary investigators, working closely with multidisciplinary teams. Coordinated trial participants, covering informed consent, screening, and inclusion, while ensuring patient safety and compliance.

Regulatory Compliance Patient Safety Communication Skills