RAFIU ELEGBA
Raleigh,NC
Summary
Highly skilled Clinical Research professional with over 10 years of experience in effectively coordinating, managing, and overseeing clinical trials. Proficient in ensuring compliance with regulatory standards and protocols while optimizing operational efficiency. Demonstrated expertise in participant recruitment, data management, and fostering collaborative relationships with multidisciplinary teams. Proven track record of executing trials with meticulous attention to detail and adherence to timelines, contributing to the successful completion of projects. Adept at problem-solving and implementing innovative strategies to improve trial processes, ultimately contributing to advancements in healthcare and pharmaceutical research.
Overview
12
12
years of professional experience
Work History
CLINICAL TRIAL SPECIALIST
BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE
03.2023 - Current
- Site Management Support: Aid in overseeing assigned clinical trials, including monitoring report review, protocol deviation assessment, and site visit tracking.
- Meeting Coordination: Schedule and organize study team meetings, manage agendas, document decisions, and disseminate actionable items promptly.
- Documentation Management: Assist in preparing both internal and external trial documents, ensuring alignment with GCP/ICH regulatory standards and study protocols.
- Material Creation: Develop study materials such as newsletters and templates to facilitate trial-related communications.
- Vendor Collaboration: Liaise with CROs and clinical vendors to ensure deliverables meet timelines and maintain effective communication.
- Quality Assurance: Identify, address, and communicate quality and compliance concerns, oversee site payments, and maintain study FAQ lists.
- System Maintenance: Establish and manage tracking systems supporting the entire clinical study lifecycle from start-up to close-out.
- Data Management: Input study data into relevant tools and dashboards, ensuring data accuracy and currency.
- eTMF Oversight: Contribute to the review and maintenance of eTMF, ensuring proper management and oversight.
- Financial Oversight: Review and track invoices against the study budget to ensure financial compliance.
- Operational Initiatives: Participate in clinical operations by aiding in the creation and enhancement of standardized trial tools, processes, and procedures.
SENIOR CLINICAL RESEARCH ASSOCIATE
MEDPACE
05.2020 - 03.2023
- Project Oversight: Conduct on-site monitoring in alignment with project timelines, meeting all compliance requirements.
- Meeting Management: Actively contribute to project and departmental meetings, demonstrating accountability for meeting content.
- Report Accuracy: Produce meticulous site monitoring reports, follow-up letters, and documentation in line with Sponsor SOPs, ensuring timely submissions.
- Issue Resolution: Ensure efficient resolution of site issues and timely completion of associated action items.
- System Proficiency: Enter and manage site visits, letters, reports, and communication logs into the Clinical Trial Management System, maintaining data accuracy and consistency.
- Regulatory Compliance: Complete Regulatory Binder and Investigational Product reconciliation to maintain study compliance.
- Communication Excellence: Regularly engage with assigned sites, fulfilling study communication requirements effectively.
- Expense Management: Submit expense reports within prescribed UBC timelines and adhere to Travel Guidelines consistently.
- SOP Adherence: Demonstrate commitment to SOP review and compliance within specified deadlines.
- Training and Mentorship: Act as an Assess-Instruct-Mentor leader, providing guidance to team members on visit conduct, documentation, and protocols. Mentor other Clinical Research Associates and assist in training programs.
- Presentation Support: Assist in the preparation and delivery of presentations for CRA training, departmental sessions, and sponsor-specific training.
CLINICAL RESEARCH ASSOCIATE II
MEDPACE
01.2016 - 05.2020
- Created, maintained, and reviewed monitoring standard operating procedures, monitoring tools for conducting monitoring tasks including monitoring plans, monitoring reports, corrective, and preventive action plans
- Developed strong site relationships and ensured continuity of site relationships through all phases of the trial
- Ensured compliance with the clinical trial protocol, check clinical site activities, made on-site visits, reviewed case report forms (CRFs), and communicated with clinical research coordinators
- Conducted pre-study visits to evaluate the suitability of investigational sites for the investigation study and ensured the availability of facilities, resources, and qualified and experienced personnel.
CLINICAL RESEARCH ASSOCIATE I
MEDPACE
01.2014 - 01.2016
- Identified conducted, topic protection, data integrity concerns, and retrain site staff accordingly
- Provided preparation and instructions to designated site staff for performing the analysis in compliance with guidelines, SOPs, trial relevant practices, and applicable regulations
- Provided on-going training to test site staff, when required, on the proper conduct of the experiment
- Ordered and preserved research records, including consent and consent forms, registries, and patient charts
- Demonstrated the ability to multi-task and execute multiple tasks against ambitious deadlines.
CLINICAL RESEARCH COORDINATOR
Methodist Healthcare
08.2013 - 01.2014
- Prepared routine reports on study patient screening, eligibility, enrollment, and retention
- Maintained regular communication with the study team and study sponsor to ensure communication of required information
- Informed consent process, adverse event monitoring, and reporting according to protocol guidelines
- Coordinated assigned study monitoring and auditing visits with the principal and other investigators, and internal/external auditors
- Attended meetings as requested and participate in outreach and informational programs to educate the community about research opportunities as needed
- Assisted with research-related fundraising events and publications as needed
- Processed and shipped study specimens including blood, urine, and CSF samples.
RESIDENT DOCTOR / CLINICAL RESEARCH PROFESSIONAL
LAGOS STATE, UNIVERSITY TEACHING HOSPITAL
07.2012 - 08.2013
- Collected study data and entered information into data base
- Participated in informed consent process
- Obtained appropriate signatures and dates as required by the methodology (proposal)
- Assisted in screening participants for eligibility, maintaining source documents and subject files
- Ensured AE and SAE are correctly and appropriately recorded to stipulated timeline
- Implemented therapeutic regimens involving medications and other interventions to mitigate symptoms and prevent reoccurrence
- Interviewed patients concerning physical complaints, discussed symptoms, asked questions, and suggested treatment options
- Ordered and executed various tests, analyses, and diagnostic images to provide information on patient condition
- Monitored post-operative recovery and educated patients on at-home recovery
- Diagnosed and treated patients suffering from chronic conditions
- Teamed with other physicians, specialists, and health care providers to provide well- rounded care for complex cases
- Treated and monitored care of geriatric patients at local long-term care facility.
Education
BACHELOR of MEDICINE,BACHELOR of SURGERY -
IGBINEDION UNIVERSITY
OKADASkills
THERAPEUTIC AREAS:
- Oncology: Solid Tumor, Breast Cancer, Colon Cancer and CAR-T Cell, Lung Cancer, Leukemia and Lymphoma
- Neurology/psychiatry : Multiple Sclerosis, Parkinson Disease, Dementia and ADHD,
- Essential tumor ,Schizophrenia
- Infectious Disease: RSV, HPV, HIV, TB
- Rare Diseases: Sickle Cell
- Medical Device: Pacemaker , IVD
- Cardiovascular Disease: Hypertension, Heart Failure
- Vaccines : HPV, COVID, TB
- Ophthalmology: Dry Eye, Macular Degeneration
- Endocrine: Diabetes
SYSTEMS OR TECHNOLOGY EXPERIENCE:
- CTMS: eClinical ,Siebel and VeevaVault
- EDC: Medidata Rave, Inform 61, Trialmaster, Datalabs and VeevaVault
- ETMF: VeevaVault
- IWRS: Endpoint, Clinphone and Suvoda
- BSM/ERP: Coupa and D365
Timeline
CLINICAL TRIAL SPECIALIST
BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE
03.2023 - Current
SENIOR CLINICAL RESEARCH ASSOCIATE
MEDPACE
05.2020 - 03.2023
CLINICAL RESEARCH ASSOCIATE II
MEDPACE
01.2016 - 05.2020
CLINICAL RESEARCH ASSOCIATE I
MEDPACE
01.2014 - 01.2016
CLINICAL RESEARCH COORDINATOR
Methodist Healthcare
08.2013 - 01.2014
RESIDENT DOCTOR / CLINICAL RESEARCH PROFESSIONAL
LAGOS STATE, UNIVERSITY TEACHING HOSPITAL
07.2012 - 08.2013
BACHELOR of MEDICINE,BACHELOR of SURGERY -
IGBINEDION UNIVERSITY
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