Ayo Mabinuori
Clinical Research Professional
Minneapolis,MN
Summary
Results-driven Clinical Research Professional with extensive experience in Phase I-IV clinical trials. Expert in ICH-GCP guidelines, FDA regulations, and clinical trial processes. Skilled in utilizing EDC and CTMS systems, with a strong background in diverse therapeutic areas. Known for attention to detail and ensuring quality and compliance in clinical research.
Overview
12
12
years of professional experience
Work History
Clinical Research Associate II
Duke Clinical Research Institute
11.2022 - Current
- Manages and monitors all aspects of clinical trials per study protocol, SOPs, ICH, and GCP guidelines
- Conducts site selection and study monitoring, ensuring compliance with drug safety and regulatory guidelines.
- Assist in investigator selection and qualification, ensuring investigators had adequate resources to conduct trials.
- Serves as the primary contact for assigned research sites, ensuring investigators, staff, and facilities remain adequate throughout the trial.
- Provides study status updates to team members and project management, resolving site issues and facilitating project timelines.
- Investigates and reports on patients’ safety and site safety issues and verified informed consent procedures and protocol requirements to protect subjects following regulatory standards.
- Reviews informed consent procedures, source documents, and medical records to ensure accurate data reporting and subject eligibility.
- Schedules and conducts pre-study, initiation, interim monitoring, and closeout visits, ensuring protocol and regulatory compliance.
- Performs investigational product accountability and reconciled site regulatory binders to ensure document completeness and compliance.
- Identifies protocol deviations and risks to subject safety/data integrity, generating and managing queries with site personnel.
- Participates in initial and ongoing protocol and CRF training at the study site, ensuring the site's essential regulatory and regulatory documents were complete and current from study start-up through closeout.
- Collaborates with clinical study site and sponsor to troubleshoot and resolve study-related issues.
- Prepares accurate and timely high-quality written trip reports, confirmation, and follow-up letters within SOP and monitoring plan timelines.
- Hired and trained over 150 research subjects and monitored progress, answered questions and provided guidance during course of clinical study.
- Hired and trained over 150 research subjects and monitored progress, answered questions and provided guidance during course of clinical study.
Clinical Research Assistant
Center for Clinical Care and Clinical Research
09.2016 - 05.2021
- Coordinated and attended study-related visits (SSVs, SIVs, IMVs, COVs).
- Reviewed and ensured proper collection and storage of study data.
- Evaluated regulatory documents for compliance with GCP principles.
- Coordinated IMVs for HIPAA compliance.
- Conducted data entry and query resolution as per protocols and CRF requirements.
- Maintained inspection readiness of ISF, ensuring compliance with SOPs and regulatory guidelines.
- Ensured adherence to ICH/GCP, FDA, IRB, and internal SOPs.
- Participated in study-specific meetings, teleconferences, and training sessions.
- Assisted with research protocol development.
Clinical Study Coordinator
Baptist Health Medical Center
04.2013 - 08.2016
- Gathered, processed, and shipped lab specimens accurately and efficiently.
- Screened patient records, databases, and physician referrals to identify prospective research study candidates.
- Collected data and adhered to research protocols, operations manuals, and case report form requirements.
- Ensured compliance with patient care protocols and clinical trial operations.
- Collaborated with principal investigators and sponsors to facilitate daily trial activities and ensure protocol adherence.
- Followed informed consent processes and maintained comprehensive records.
- Monitored unit budget to meet financial objectives and manage funding effectively.
- Ensured regulatory compliance by meticulously maintaining documentation for study activities.
- Contributed to successful grant applications by assisting with proposal preparation, submission, and follow-up activities.
- Maintained up-to-date knowledge of industry best practices, regulations, and advancements in clinical research coordination methodologies.
- Assisted investigators with publication efforts by contributing to manuscript development, editing, and submission processes.
- Enhanced patient satisfaction by efficiently coordinating and managing study schedules.
- Provided comprehensive training to new staff members, ensuring seamless integration into existing workflows while maintaining high-quality work standards.
- Facilitated timely enrollment of participants through targeted recruitment strategies.
Education
Bachelor of Science -
University of Lagos
Nigeria12-2009
Skills
- Clinical Trials Knowledge: Phases I-IV, Study Documents (Protocols, CRFs, IB, Study Plans, etc)
- Clinical Trial Process: Study Start-Up, Conduct, and Close-Out
- Regulatory Guidelines: FDA, ICH-GCP, and other relevant guidelines
- ETMF: Veeva, Florence, Medidata Rave, SureClinical
- IWRS: 4G Clinical, Veeva, Oracle, Endpoint, Suvoda, Medpace
- CTMS/ISF: Complion, Florence, Box Folder, Citrix
- EMR: EPIC, Cerner, AdvancedMD
- Lab/Imaging: Medpace, LabCorp, Quest Diagnostics, Clario
- EDC: Medidata Rave, Veeva, Viedoc, Inform, Zelta
Timeline
Clinical Research Associate II
Duke Clinical Research Institute
11.2022 - Current
Clinical Research Assistant
Center for Clinical Care and Clinical Research
09.2016 - 05.2021
Clinical Study Coordinator
Baptist Health Medical Center
04.2013 - 08.2016
Bachelor of Science -
University of Lagos
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