Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives. Knowledgeable adept at recognizing clinical values and abstract data from source documents. Uses analytical skills to identify data or patient safety issues.
Hi, I’m
Ademuyiwa Ogunfowora
Sugar Land,TX
Summary
Overview
5
years of professional experience
Work History
Aspira InternationalPasadena, TX
In-House Clinical Research Associate
01.2022 - Current
Job overview
- Served as main contact for project team and investigative sites, conducted site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session (outbound or inbound) with sites
- Monitored site performance and implemented action plans for sites not meeting expectations, in conjunction with the CRA and CTL
- Assisted CRAS with preparation for site visits (i.e running reports, QC of files (checking for missing documents), resolving action items from previous visits), Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management
- Assisted with the coordination of study visits and shipment of drug
- Managed sites to ensure subjects are complying with protocol requirements, study visits and timelines
- Demonstrated an understanding of the purpose of CTMS, how to use it and how to navigate within the different sections
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Checked electronic data capturing systems for integrity and compliance.
- Reported to project manager for issues related to overall study status.
- Conducted all activities according to defined project-specific quality and performance standards.
- Performed pre-study and interim visits to check on study activities.
- Participated in educational training, activities and professional development programs.
- Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
- Performed pre-study site evaluations, site initiations, interim monitoring and study close-out visits while collecting regulatory documentation.
- Monitored site activities and sent follow-up letters to participants.
- Evaluated proof of eligibility and consent for participants.
- Supported quality control program by scheduling site assessment visits for the project and conducting monitoring visits.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
- Attended meetings and reported on activities and resolutions.
- Communicated with vendors to deliver appropriate clinical supplies to sites and meet ongoing operational demands.
- Designed trial materials and developed supply study centers with sufficient materials to enhance recruitment.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
Aspira International Pasadena, TX
Clinical Trials Administrator II
01.2020 - 12.2021
Job overview
- Documented and tracked study activities using relevant forms and tools
- Project Management System
- Prepared study site files in accordance with relevant SOPs
- Created and maintained contact list of study team members, study sites and external suppliers/contract organizations
- Took minutes and created documentation for sponsor or internal teleconferences
- Maintained tracking systems for study supplies and investigator payments
- Assisted in the tracking and filing of documents for all clinical trials into database
- Supported Investigator Meetings
- May have supported mentoring less experienced CTAS on project or department tasks and requirements
- Liaised with all other departments to ensure the smooth running of the study
- Collected, validated, and distributed information to employees.
- Networked with industry professionals to exchange best practice knowledge and stay abreast of latest developments.
- Managed company schedule to coordinate calendar and arrange travel.
- Maintained database systems to track and analyze operational data.
- Observed packing operations to verify conformance to specifications.
- Collected, arranged, and input information into database system.
- Conducted regular reviews of operations and identified areas for improvement.
- Performed other duties as required by the department or project team.
Aspira InternationalPasadena, TX
Clinical Trials Administrator I
01.2018 - 12.2019
Job overview
- Maintained and managed data entry into clinical tracking systems to ensure that the project information was current, accurate and complete
- ICH/GCP
- Performed other duties as required by the department or project team
- Liaised with all other Aspira departments to ensure the smooth running of the study
- Communicated with sites regarding trial start-up, conduct and close-out activities
- Assisted in the preparation of study site files in accordance with relevant SOPs
- Created and maintained contact list of study team members, study sites and external suppliers/contract organizations
- Organized, drafted and circulated minutes of the project team meetings (both internal project team meetings and project team meetings with the sponsor)
- Assisted in setting up and maintaining tracking systems for e.g
- Study supplies and investigator payments
- Assisted in the tracking and filing of documents for all clinical studies into database
- Mentored new clinical staff members for proper onboarding and orientation processes.
- Collected/reviewed of regulatory documents required in accordance with project requirements and
- Coordinated, monitored, assigned, and documented patient and clinical care activities.
Education
Clarkson UniversityPotsdam, NY
MBA from Healthcare Management
09.2022
University Overview
Clarkson UniversityPotsdam, NY
Master of Science from Healthcare Data Analytics
09.2022
University Overview
Lagos State UniversityLagos, Nigeria
M.D. from Medicine And Surgery
04.2009
University Overview
Skills
- Trial Oversight
- Microsoft Office (Word, Excel, Publisher, PowerPoint)
- Site Management
- Coordinating Supplies
- Scheduling Proficiency
- Good Work Ethic
- Research Experience
- Trip Reports
- Patient Safety
- Monitoring Visits
- Patient Recruitment Strategies
- Clinical Research Monitoring Experience
- Database Locking
- Report Writing
- Data Collection
- Developing Study Tools
- Clinical Research Monitoring
- Data Evaluation
- Detailed Documentation
- Meeting Reporting
- Status Reporting
- Team Training
- Protocol Adherence
- Project Management
- Quality Control
- Research and Development
- Protocol Development
- Action Planning
- Investigator Meetings
- Product Inventories
- Site Evaluations
- Interdepartmental Collaboration
- Area of Study Expertise
- Coordinating Site Operations
- Reviewing Data Standards
- Trial Close
- Clinical Documentation
- Study Coordination
- Managing Adverse Events
- Trial Methodologies
- Schedule Monitoring
- Case Report Management
- Drug Storage Procedures
- Participation Reviews
- Regulatory Reporting
- Site Investigation Reports
- Document Verification
- Subject Tracking Tools
- Project Monitoring
- Integrated Medical Reporting
- Pre-Trial Procedures Mastery
- Laboratory Results Management
- Potential Subject Evaluation
- Site Selection
- Adverse Event Documentation
- Enrollment Oversight
- Study Protocols
- Research Sops Understanding
- Good Clinical Practice
- Informed Consent
- Dispensing Oversight
- Study Monitoring
- Site and Study Management
Additional Information
Additional Information
- Certificate of Learning: T.M. V5.0 Study Coordinator, OmniComm System Inc,
- Certificate of Completion: Invicro’s site qualification training, Cristcot CHS 1221 study,
- Certificate of Completion: Certified Professional Healthcare Quality,
- Forum of Medical Affairs on Rare Diseases,
- Clinical Trial Operations, John Hopkins
- Board Certified Medical Affairs Specialist
- Training in Good Clinical Practice (GCP) and International Conference of Harmonization (ICH)
- Certificate of Completion: Clinical Research, National Institutes of Health
Affiliations
Affiliations
America College of Healthcare Executives
Accreditation Council of Medical Affairs Specialist
Exchange Club Of Sugarland
Timeline
In-House Clinical Research Associate
Aspira International
01.2022 - Current
Clinical Trials Administrator II
Aspira International
01.2020 - 12.2021
Clinical Trials Administrator I
Aspira International
01.2018 - 12.2019
Clarkson University
MBA from Healthcare Management
Clarkson University
Master of Science from Healthcare Data Analytics
Lagos State University
M.D. from Medicine And Surgery
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