BLESSING OBORO
Summary
Highly organized and compliance-driven professional with experience in clinical research operations, regulatory documentation, and quality management. Skilled in ensuring adherence to ICH-GCP, ISO, and local regulatory frameworks across all trial phases. Adept at document control, TMF/eTMF oversight, and data verification. Experienced in supporting inspection readiness, internal audits, and process improvement initiatives that ensure data integrity and regulatory compliance.
Overview
6
6
years of professional experience
2022
2022
years of post-secondary education
1
1
Certification
Work history
Clinical Research Associate
Merit Clinical Research
Las Vegas, Nevada
04.2023 - 11.2025
- Support site initiation and close-out processes ensuring regulatory document readiness, protocol compliance, and audit preparedness.
- Conduct site qualification, initiation, interim monitoring, and close-out visits in compliance with SOPs, GCP guidelines, and regulatory requirements.
- Perform comprehensive source data verification (SDV) to ensure accuracy, completeness, and regulatory compliance.
- Lead and coordinate the team of CRAs across multiple study sites to ensure monitoring activities align with study timelines and milestones.
- Review Investigator Site File (ISF) and Trial Master File (TMF/eTMF) for regulatory accuracy and audit traceability.
- Perform subject data review using EDC systems (Medidata Rave, Veeva, InForm, iMednet, Zelta) to ensure completeness and accuracy.
- Ensure timely collection and filing/upload of critical documents onto the TMF/eTMF as applicable per ICH-GCP guidelines.
- Analyze data reports within IRT and cloud-based storage systems to maintain compliance.
- Report and track SAEs and follow-ups, ensuring appropriate documentation and escalation.
- Write comprehensive monitoring reports for SIV, IMV, and COV visits, addressing protocol deviations and site performance.
- Collaborate with cross-functional teams to maintain regulatory compliance and resolve data queries efficiently.
Medical Data Specialist
54gene
Lagos, Nigeria
01.2022 - 08.2022
- Ensured accuracy and compliance of informed consent forms uploaded to EDC portals.
- Assisted in policy development for clinical research operations.
- Reviewed and harmonized research procedures to meet ethical and regulatory standards.
- Configured and monitored user access for EDC portals, troubleshooting authentication issues.
- Maintained and organized patient data within an Information Management System in line with data protection regulations.
- Contributed to database creation and management for study participants.
- Standardized study questionnaires to align with regulatory and stakeholder requirements.
Data Collector
Mpharma
Lagos, Nigeria
07.2019 - 12.2021
- Assisted in the creation of meaningful reports based on collected data that highlighted key trends and insights for decision makers.
- Conducted quality assurance checks on data collected from field activities.
- Piloted the integration of QR codes in inventory tracking, reducing variances by 80%.
Pharmacology Intern
Lagos University Teaching Hospital
Lagos, Nigeria
11.2019 - 01.2020
- Assisted in antiretroviral therapy administration under pharmacist supervision.
- Conducted pharmacovigilance activities to improve patient safety.
- Contributed to a positive team environment by collaborating with fellow interns on group projects and presentations.
- Conducted research for various projects, leading to well-informed decisions and successful outcomes.
Education
Bachelor of Science - Pharmacology And Toxicology
University of Lagos
Lagos, NigeriaSkills
- Clinical Site Monitoring (SQV, SIV, IMV, COV)
- Risk-Based Monitoring Implementation
- Serious Adverse Event (SAE) Reporting & Follow-up
- Good Clinical Practice (GCP) & Protocol Adherence
- Data Query Management & Issue Escalation
- Ethical & Regulatory Compliance
- Electronic Data Capture (EDC) Systems: Medidata Rave, Veeva, InForm, iMednet, Zelta
- Source Data Review (SDR) & Source Data Verification (SDV)
- Investigator Site Files (ISF) & Regulatory Document Management
- Case Report Form (CRF) Review
- Stakeholder Communication & Collaboration
THERAPEUTIC EXPERTISE
- Neurology: Schizophrenia (Phase III)
- Respiratory: Asthma (Phase I & II), Idiopathic Pulmonary Fibrosis (IPF, Phase III)
- Cardiovascular: Severe Tricuspid Regurgitation (Pre-Market)
- Ophthalmology: Cataract (Phase II)
- Oncology: Colorectal Cancer (Medical Device - AI, Class I)
- Oncology: Non-SmallCell Lung Cancer (Phase I)
- Oncology: B-Cell Malignancies (Phase II)
- Oncology: Myeloid Malignancies (Phase II)
- Oncology: Chronic Lymphocytic Leukemia (Phase III)
Certification
- Good Clinical Practice (GCP) Course – CITI Program, Issued March 2025
- Group 1 - Investigators – CITI Program, Issued July 2022
- Artificial Intelligence (AI) and Human Subject Protections – CITI Program, Issued January 2023
Timeline
Clinical Research Associate
Merit Clinical Research
04.2023 - 11.2025
Medical Data Specialist
54gene
01.2022 - 08.2022
Pharmacology Intern
Lagos University Teaching Hospital
11.2019 - 01.2020
Data Collector
Mpharma
07.2019 - 12.2021
Bachelor of Science - Pharmacology And Toxicology
University of Lagos