Michael Okunlola
Summary
Knowledgeable Clinical Research operations with 8 years of experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities. Thorough knowledge of MHRA, EMA, FDA and ICH-GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed. Motivated and methodical clinical research professional arranging sites, operations and regulatory functions.
Overview
10
10
years of professional experience
Work History
Access Service Representative
Baylor Scott and White
USA
05.2023 - Current
- Ensuring smooth communication between patients, doctors, and other healthcare professionals
- Triage phone calls or facilitating referrals to different specialists
- Ensured compliance with organizational policies related to admission process, discharge planning, pre-authorizations and certifications.
- Utilized various software programs such as MS Office Suite for data entry purposes.
- Process billing information and distribute payment information
- Follow up with patient medical appointment
- Updating patient demographics
- Provided information about clinic policies and procedures as well as answered general questions from patients.
- Processed credit card transactions quickly and accurately while adhering to all applicable laws and regulations governing such transactions.
Trainee Clinical Trial Associates
Quotient Science
United Kingdom
03.2022 - 11.2022
- Assisted several field Clinical Research Associates (CRAs) in reconciling source data verification/source data review SDV/SDR, monitoring, as well as creating and updating study start-up documents
- Possess comprehensive knowledge of clinical research operations from the perspective of a Contract Research Organization (CRO), using the International Conference on Harmonization (ICH) as a reference and have extensive familiarity with CTMS, eTMF, SQL, SharePoint, MS office and regulatory documents
- Understanding of clinical trial protocols and site specifications, as well as a deep understanding of scientific/medical objectives of the clinical trials
- Supported due diligence, competitive landscape intelligence, forecasting and analytics as well as enrollment/optimization modeling, epidemiology and site identification intelligence and Real-World Evidence to support Clinical Operations strategies and Patient Recruitment
- Ability to manage large scale and multi-clinical centres within the region
- Maintaining effective communication with study sites, investigator, and other team members.
- Conducted in-depth research in order to write effective proposals, agreements and contracts.
- Leads the strategic review, in-depth regional review, and engagement of cross-functional team to determine and inform on regional capabilities to conduct protocols and successfully meet/exceed targeted enrollment.
Healthcare Officer - Monitoring
Pathway For Care
United Kingdom
03.2019 - 02.2022
- I overseen compliance with healthcare laws, regulations, and standards to ensure that healthcare staff operate within legal and ethical boundaries. This involves monitoring and enforcing regulations, licensing healthcare professionals, and addressing any violations or complaints.
- Documenting patient information, medical histories, treatment plans, medication administration, and any observed changes in patients' conditions.
- I have worked closely with healthcare providers, administrators, and other stakeholders to ensure effective coordination and collaboration. I facilitate communication, information sharing, and decision-making to improve the overall functioning of the patient.
- I collect and analyze healthcare data to identify trends, patterns, and areas of improvement. And I also use this information to generate reports, assess outcomes, inform decision-making, and drive policy development
- Assisted in developing procedures for monitoring systems and responding to alerts.
- Analyzed survey data from beneficiaries to evaluate program impact.
- Facilitated workshops with external stakeholders to discuss healthcare program outcomes.
Trial Monitor/CRA
Innovative Biotech Ltd
Nigeria
06.2014 - 02.2019
- I monitored the progress of clinical trials at various investigational sites. This includes verifying that the study sites comply with the trial protocol, Good Clinical Practice (GCP) guidelines, and relevant regulations. I also conducted regular on-site visits to review data, monitor patient recruitment and enrollment, and ensure the safety and well-being of participants.
- I was responsible for ensuring that the electronic Trial Master File (eTMF) is audit-ready through quality control measures. This involves overseeing the eTMF documents on a day-to-day basis and generating reports to accurately assess their completeness and accuracy.
- Ensured subject’s safety by monitoring AEs, SAEs and providing support when needed
- Ensuring the site meet NAFDAC regulations
- I maintained comprehensive and accurate documentation of all trial stages and write reports for regulatory authorities and sponsors
- I maintained constant communication with the investigational site staff, such as study coordinators and principal investigators. I also provide guidance and support, address queries, and ensure that all parties involved remain updated on the trial progress.
- I evaluated study protocols and draft essential documentation, such as informed consent forms and case report forms. I ensured that the trial design follows ethical and regulatory guidelines.
- Conducted site initiation visits and monitored ongoing studies at investigator sites.
- Prepared reports, summarizing study progress and results for senior management review.
Skills
- Data Management Proficiency
- Case Report Management
- Problem-Solving Abilities
- Outlook
- EPIC, EDC, CTMS, PowerPoint, MS Excel
- SQL
- SharePoint, Database and MS Office
- Microsoft Suite
- eTMF/Vault
- Power BI
Clinical Research Training
Research Training covering Core Competencies including
● ICH GCP E6 R (2)
● FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46
● Data Management
● Informed Consent Process
● Clinical Trial Operations from feasibility through close-out
● Good Documentation Practice (GDP) following ALCOA-C principles
● Identification and reporting of AEs and SAEs
● Quality Assurance, Monitoring and Query Resolution
● Comprehension and Execution of Clinical Trial Protocols
● Maintaining a regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs and other Investigator Site File (ISF) document
Education Attained
- MS, Information Technology
- Bachelor, Banking and Finance
Timeline
Access Service Representative
Baylor Scott and White
05.2023 - Current
Trainee Clinical Trial Associates
Quotient Science
03.2022 - 11.2022
Healthcare Officer - Monitoring
Pathway For Care
03.2019 - 02.2022
Trial Monitor/CRA
Innovative Biotech Ltd
06.2014 - 02.2019