Linda Nwabundu
Niagara Falls,ON
Summary
Certified Clinical Research Professional (CCRP) with over 5 years of experience in clinical trial coordination, site monitoring, and regulatory compliance, particularly within multi-center oncology and precision medicine studies. Proficient in Health Canada, FDA, and ICH-GCP regulations, with hands-on expertise in conducting site evaluations, monitoring compliance, and managing informed consent processes. Adept at working with crossfunctional teams to manage and analyze patient-reported data in clinical trials, ensuring alignment with regulatory and scientific standards. Passionate about developing patient-centric solutions to improve clinical outcomes and contribute to drug development.
Overview
6
6
years of professional experience
Work History
RTSM Associate
Axiom Real-Time Metrics
Mississauga, Canada
09.2021 - Current
- Conducted remote and on-site monitoring visits to ensure compliance with Health Canada and ICH-GCP standards across multi-centre trials
- Evaluated site performance by identifying compliance issues and recommending corrective actions
- Managed the preparation and validation of study-specific documentation, including informed consent forms and trial protocols
- Collaborated with cross-functional teams and site staff to address operational challenges and provide recommendations for improved trial efficiency
- Oversaw randomization processes and ensured accurate drug dispensation while maintaining protocol compliance
- Contributed to database management by validating trial data and generating monitoring reports to document observations and recommendations
Clinical Research Intern
International Research Academy, CRA School of Montreal
Montreal, Canada
03.2021 - 07.2021
- Supported multi-centre clinical trials by monitoring trial documentation, including REB submissions and patient consent forms
- Conducted quality checks on trial data in eTMF and CTMS systems to ensure compliance with regulatory and sponsor requirements
- Assisted in the preparation of Clinical Trial Applications (CTAs) and amendments for submission to Health Canada
- Evaluated trial sites' adherence to GCP guidelines and proposed operational improvements to enhance compliance and efficiency
- Contributed to study start-up activities by assisting in the design and review of informed consent forms and study protocols
House Officer
Nigerian Army Reference Hospital
Lagos, Nigeria
09.2018 - 01.2020
- Coordinated study activities by obtaining informed consent, scheduling participant visits, and ensuring protocol compliance
- Monitored adverse events (AEs) and abnormal results, reporting to investigators and recommending corrective actions
- Documented clinical trial data, ensuring accuracy, completeness, and compliance with regulatory standards
- Liaised with investigators and site staff to resolve discrepancies and maintain operational efficiency
- Analyzed site data for quality improvement initiatives and supported the implementation of corrective measures
Education
GCP for Clinical Trials with Investigational Drugs and Biologics -
CITI Program
01.2024
GCP for Clinical Investigation of Devices -
CITI Program
01.2024
Post Graduate Diploma - Clinical Research Professional
International Research Academy
Montreal, Canada01.2021
TCPS 2: Course on Research Ethics and Certification -
Panel on Research Ethics
Canada01.2021
Bachelor of Medicine and Bachelor of Surgery -
Ebonyi State University
Nigeria01.2017
Skills
- Health Canada regulations
- ICH-GCP
- FDA guidelines
- REB submissions
- Site monitoring
- Compliance auditing
- Corrective action planning
- Preparing informed consent forms
- Regulatory documentation
- SOPs
- Managing multi-center trials
- Remote monitoring
- On-site monitoring
- Clinical Trial Applications (CTAs)
- Protocol Amendments
- Regulatory queries
- Precision medicine initiatives
- Single-patient studies
- Organizational skills
- Analytical skills
- Problem-solving skills
Education/Certification
- Post Graduate Diploma Clinical Research Professional, 2021, International Research Academy, CRA School of Montreal, Montreal, Canada
- Bachelor of Medicine and Bachelor of Surgery, 2017, Ebonyi State University, Nigeria, (Degree Evaluated by Medical Council of Canada {MCC})
- TCPS 2: Course on Research Ethics and Certification, 2021, Panel on Research Ethics, Canada
- GCP for Clinical Trials with Investigational Drugs and Biologics, 2024, CITI Program
- GCP for Clinical Investigation of Devices, 2024, CITI Program
Timeline
RTSM Associate
Axiom Real-Time Metrics
09.2021 - Current
Clinical Research Intern
International Research Academy, CRA School of Montreal
03.2021 - 07.2021
House Officer
Nigerian Army Reference Hospital
09.2018 - 01.2020
GCP for Clinical Trials with Investigational Drugs and Biologics -
CITI Program
GCP for Clinical Investigation of Devices -
CITI Program
Post Graduate Diploma - Clinical Research Professional
International Research Academy
TCPS 2: Course on Research Ethics and Certification -
Panel on Research Ethics
Bachelor of Medicine and Bachelor of Surgery -
Ebonyi State University
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