ABIGAIL ADEMUWAGUN
GTA,ON (Permanent Resident)
Summary
Aspiring regulatory affairs professional with a strong passion for ensuring food, drug and cosmetic safety through adherence to regulatory standards. Proficient in regulatory affairs terminology and processes, including FDA regulations and guidelines. Familiar with IND and NDA submissions, as well as the regulatory requirements for ANDA and BLA approvals. Knowledgeable in Chemistry, Manufacturing, and Controls (CMC) and adept at interpreting Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations. Understanding of Good Clinical Practice (GCP) standards and their importance in ensuring the integrity of clinical trials. Ability to navigate the Code of Federal Regulations (CFR) to identify relevant regulatory requirements and compliance obligations.
Overview
8
8
years of professional experience
Work History
Clinical Researcher
Covenant University Centre For Research Innovation And Discovery
2017.11 - 2023.12
- Improved project monitoring and team coordination by 20% by developing clinical project plans such as project deviation plan, project schedules, communication plans, recruitment and retention plans
- Reduced screen failures and ethical concerns by 50% by managing subject recruitment, prescreening, screening, sample collection and facilitation of Informed Consent process
- Led development of site SOPs and trained new study staff on GCP and study protocol
- Expedited study start-up and progress by 20% by supervising Institutional Review Board (IRB) and regulatory documents submission
- Collaborated with sponsor and CRA for study success, reviewed follow up letters, implemented needed action items and filed study documents into Institution site
- Collaborated to generate study project progress reports for review by principal investigator and site managers.
- Enhanced patient safety in clinical trials through rigorous monitoring and reporting of adverse events.
- Developed robust study protocols to ensure accurate data collection and analysis for reliable results.
- Increased participant recruitment rates by designing targeted outreach campaigns and collaborating with healthcare providers.
Clinical Research Coordinator
Lagos University Teaching Hospital
2016.12 - 2017.10
- Led timely entry of source data into eCRF/EDC, thereby improving data integrity and accuracy by 30%
- Led project start-up at site by tracking site-specific submissions to by Institutional Review Board (IRB) and monitoring approval timelines for all essential documents
- Improved communication efficiency and issue resolution by 50% by serving as key point of contact between sponsor/CRO and site
- Improved comprehensive site documentation (for future audits) by 40% by filing all monitoring visit follow-up letters, study documents, source data documents, ICFs, CRFs and training logs in investigator's site file (ISF)
- Maintained 100% protocol adherence and team competence by organizing and conducting protocol training sessions during Site Initiation Visits (SIV)
- Addressing closing queries and managing return of investigational products (IP) according to study protocol.
Clinical Research Assistant
AIDS Prevention Initiative in Nigeria (APIN)
2016.01 - 2016.11
- Reduced site's data query backlog by 50% by following up with all queries from data management team, clinical project manager (CPM) and Clinical research associate (CRA) for necessary corrections
- Ensured 100% compliance with ICH-GCP guidelines by meticulously overseeing ISF and project records
- Improved efficient data monitoring by 50% by tracking and overseeing Case Report Forms (CRFs) and source data, ensuring accurate and audit-ready documentation and applying ALCOA++ principles of good documentation practice
- Compiled research documents for Institutional Review Board (IRB) submissions, encompassing study protocols and investigator credentials, across multiple projects.
Education
Regulatory Affairs Training Program - Regulatory Affairs
Duke University School of Medicine
USA11.2023
Ph.D. - Biochemistry
Covenant University
Nigeria10.2023
Master of Science - Biochemistry
University of Lagos
Nigeria07.2017
Skills
- Microsoft Outlook, Word, Excel and PowerPoint
- Preclarus, Clarity, Microsoft project, JIRA, Trello, Agile methodologies (Scrum, Kanban, Sprint Planning, retrospectives)
- Clinical Trial Management Systems (CTMS) (Medidata CTMS, Oracle Siebel CTMS, Veeva Systems, REDCap)
- Electronic Data Capture (EDC) Systems: Medidata Rave, Oracle Clinical
- Documentation skills: Microsoft Word, ALCOA++ principles, Office 365, Google docs, IBM SPSS, Strong IT skills, in particular MS Excel
- Strong communicator, Ability to work effectively under pressure
- Site Management and Monitoring: Medidata Rave, Oracle Siebel CTMS
- Risk and Quality Management: Risk Identification, Risk Analysis, Risk Mitigation, Quality Assurance & Control, Six Sigma
- Stakeholder Management, Stakeholder Analysis, Status Reports, Budget Management: Cost Estimation, Budget Tracking, Earned Value Management (EVM)
- Knowledge of regulatory landscape: Knowledgeable of regulatory requirements of FDA and Health Canada such as ICH-GCP, FDA Form 1572, and QIU
- Collaborative mindset, Exceptional organizational, Communication skills, Attention to details and multi-tasking, Clinical Data Management, Medical Writing, Clinical Study Design, Statistical Knowledge, SAP EHS Management, Strategic Clinical Planning, Clinical Development, Clinical Trial Applications.
Timeline
Clinical Researcher
Covenant University Centre For Research Innovation And Discovery
2017.11 - 2023.12
Clinical Research Coordinator
Lagos University Teaching Hospital
2016.12 - 2017.10
Clinical Research Assistant
AIDS Prevention Initiative in Nigeria (APIN)
2016.01 - 2016.11
Regulatory Affairs Training Program - Regulatory Affairs
Duke University School of Medicine
Ph.D. - Biochemistry
Covenant University
Master of Science - Biochemistry
University of Lagos
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