Mgbeodichinma Ogbodo
Summary
Analytical Clinical Research Associate with talents in project development and screening to document and report clinical study progress. Coordinates and facilitate research activities and submits protocols for regulatory approval. Serves as point-of-contact for clinical research professionals and coordinates lab samples to compile detailed data.
Overview
5
5
years of professional experience
Work History
Quality Control Inspector
Mitolo Family Farms.
05.2024 - Current
- Improved product quality by conducting thorough inspections and identifying defects in a timely manner.
- Enhanced production efficiency by implementing standardized inspection processes and procedures.
- Maintained compliance with industry regulations through meticulous record-keeping and documentation of inspection results.
- Reduced product rejection rates by collaborating with production teams to address quality issues proactively.
Group research on the development process of a biologic drug (Adalimumab)
Flinders University
03.2022 - 11.2023
- Understanding the Ethical Frameworks of a biologic drug
- Understanding of the different stages/phases involved in the production of the biological drug Legal and Regulatory Knowledge
- Informed Consent and Patient Rights
- Research Ethics
- Conflicts of Interest
- Transparency and Disclosure
- Social Responsibility
- Risk-Benefit Assessment
- Emerging Ethical Issues
- Professional Conduct.
Clinical research associate (Internship student)
Ministry of Health
03.2019 - 02.2020
- Assisted in the study preparation and coordination, development and review of study protocols, informed consent forms, and other study-related documents
- Assisted in coordinating and scheduling participant visits and study-related appointments
- Preparing and maintaining study materials and supplies
- Accompanied my supervisor in conducting informed consent discussions with participants
- Maintaining regular communication with study participants to ensure compliance and address any concerns
- Assisted in accurately collecting and recording study data, including vital signs, medical histories, and other relevant information
- Ensuring data entry and maintenance of study databases
- Assisting in the management and organization of study files and records
- Compliance and Quality Assurance which includes Ensuring that all study activities are conducted in accordance with the study protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements
- Assisting in monitoring and auditing processes to ensure data integrity and compliance
- Reporting any adverse events or protocol deviations to the study coordinator or principal investigator
- Laboratory and Specimen Handling which includes assisting in the collection, processing, and shipping of biological specimens, such as blood or urine samples
- Ensuring proper labeling, storage, and documentation of specimens
- Participating in team meetings and providing updates on study progress
- Observed my supervisor collaborating with external stakeholders, such as study sponsors or regulatory authorities, as needed
- Assisting with the preparation and submission of regulatory documents
- Managing study-related correspondence and documentation
- Performing general administrative tasks, such as filing, photocopying, and data entry
- Participated in training sessions and workshops to enhance knowledge and skills in clinical research
- Ability to Stay up to date with relevant scientific literature and developments in the field.
Education
Master of Science in Biotechnology -
Flinders University
Adelaide, South Australia01.2023
Bachelor of Science in Genetic and Biotechnology -
University of Calabar
01.2014
Skills
- Comprehensive understanding of Good Clinical Practice (GCP) guidelines and regulatory standards
- Data analysis using statistical software
- Strong analytical and problem-solving skills acquired through academic projects and research
- Excellent communication, teamwork, documentation, and presentation abilities
- Good Work Ethic
- Project monitoring
- Patient Safety
- Protocol adherence
- Quality Control
- Status Reporting
Activities
- Understanding the Ethical Frameworks of a biologic drug
- Understanding of the different stages/phases involved in the production of the biological drug
- Legal and Regulatory Knowledge
- Informed Consent and Patient Rights
- Research Ethics
- Conflicts of Interest
- Transparency and Disclosure
- Social Responsibility
- Risk-Benefit Assessment
- Emerging Ethical Issues
- Professional Conduct
Laboratory Work
- Cell-Based Assays: Assessing the biological activity of drugs or biopharmaceuticals using cultured cells
- Analytical Techniques: Using various analytical methods, such as HPLC (High-Performance Liquid Chromatography) or mass spectrometry, to analyze pharmaceutical compounds
- Validation Studies: Conducting studies to validate and ensure the reliability of manufacturing processes
- GMP (Good Manufacturing Practice) Compliance: Adhering to GMP standards in the execution of laboratory experiments, emphasizing the importance of quality control in the pharmaceutical industry
Coursework
- Clinical Research Methods and Ethics
- Advanced Molecular Biology
- Biostatistics, Data Entry and Data Analysis
- Pharmacology and Drug Development
- Cell Culture Techniques and Applications
- Clinical Trials Management
Timeline
Quality Control Inspector
Mitolo Family Farms.
05.2024 - Current
Group research on the development process of a biologic drug (Adalimumab)
Flinders University
03.2022 - 11.2023
Clinical research associate (Internship student)
Ministry of Health
03.2019 - 02.2020
Master of Science in Biotechnology -
Flinders University
Bachelor of Science in Genetic and Biotechnology -
University of Calabar
Similar Profiles
KOMALPREET KAURKOMALPREET KAUR
Quality Inspector at Zerella FarmsQuality Inspector at Zerella Farms
Aminiasi RogoiruwaiAminiasi Rogoiruwai
Machine Operator at Mitolo Family FarmMachine Operator at Mitolo Family Farm
MEGA AMALIA GHAISANIMEGA AMALIA GHAISANI
Potato Grader at MITOLO FAMILY FARMPotato Grader at MITOLO FAMILY FARM