experienced in complying with study protocols, standard operating procedures, and good clinical practices. Practiced problem-solver with strong attention to detail with 12 years’ experience in the field with strong knowledge of ICH-GCP and FDA regulations.
Overview
13
13
years of professional experience
Work History
Clinical Trial Associate
Oregon State Health University- Portland
Portland, United States
02.2024 - Current
Created and managed clinical trial databases, including data entry of source documents into the database.
Performed reconciliation between source documents and database entries to ensure accuracy of information.
Developed and maintained trial master files in accordance with GCP and ICH guidelines.
Assisted in the preparation of study protocols, case report forms, informed consent forms, investigational product labels, and other related documents.
Conducted literature searches to identify potential investigators for new studies.
Maintained tracking systems for investigator payments, regulatory documents, and other study related materials.
Prepared reports summarizing study progress from inception through closure.
Coordinated shipping of investigational products to investigative sites according to protocol requirements.
Tracked enrollment status of patients in clinical trials.
Organized meetings with sponsors and investigators regarding protocol amendments or any changes required during the course of a study.
Interacted with vendors regarding equipment maintenance or troubleshooting issues.
Conducted screening interviews to determine eligibility of possible subjects.
Study Coordinator
Velox Medical Center
Houston, United States
01.2023 - 11.2023
Identified and recruited patients eligible to enter clinical research studies
Coordinated Informed consent procedures are followed for all procedures such as blood sampling or data collection from a patient that will form part of a research project
Managed patients within research studies, promoting and maintaining effective communication with the patient and their relatives taking part in clinical research studies
Created Worksheets for the different Studies based on the Protocol and eCRF provided
Collected and interpreted appropriate data for specific research projects and entered allocated databases or case report forms in an accurate and timely manner
I entered an appropriate paper trail for specific research projects and ensured all documentation is within the ICH GCP guidelines
Coordinated arrangements for patients participating in research projects ensuring all Protocol specified tests and procedures are performed at the Appropriate time point per protocol
Provided support for clinical research study colleagues in their absence
Demonstrated politeness, courtesy, and sensitivity in dealing with patients/participants, visitors/relatives, and colleagues, establishing, and maintaining excellent customer relations
Created study participant recruitment materials for the site
Collaborated with the Clinical Project Manager, and Principal Investigator and Clinical Research Trained staff / Colleagues the ins and outs of the Job
Ensured that regulatory documents are kept securely and are up to date
Conducted clinical studies according to FDA/GCP and ICH regulations and guidelines
Scheduled subject visits within protocol windows, ensuring scheduling capacity is maximized
Completed IP accountability logs and associated information
Reported suspected non-compliance to relevant site staff
Ensured that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study
Promoted the company and built a positive relationship with patients to ensure retention
Attended site initiation meetings and all other relevant meetings to receive training on protocol
(Pre study, site initiation and Close out visit) Contacted patients, do patient bookings and follow-up calls to confirm bookings or provide information or results
Completed information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within a timeframe
Gathered and maintained source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded
Coordinated work with CRA's monitoring onsite
Created Investigator site file for the site
Created Standard operation procedure for the site
Applied for more studies for the site Created regulatory binder for the site.
Study Coordinator
QUICK CLINIC MEDICAL CENTER
Houston, United States
05.2018 - 12.2022
Identified needs of participants promptly and efficiently
Demonstrated leadership by making improvements to work processes and helping to train others
Kept patient care protocols and clinical trial operations in compliance
Collected, processed, and delivered specimens from trial participants
Organized, analyzed, and modeled study data
Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials
Assessed records of each patient, reviewed databases, and checked referrals to locate potential research study participants
Gathered and reviewed study data
Took vital signs and collected medical histories as part of study protocols
Educated participants on studies and anticipated outcomes
Worked successfully with a diverse group of coworkers to accomplish goals and address issues related to our products and services
Prioritized and organized tasks to efficiently accomplish service goals
Planned and completed group projects, working smoothly with others
Assisted with customer requests and answered questions to improve satisfaction
Adhered to standards in areas involving data collection, research protocols and regulatory reporting.
Administrator
INSTITUTE OF HUMAN VIROLOGY, LHVN
Nigeria, Nigeria
11.2014 - 03.2017
Society of Oncology and Cancer, Managing the members database
Planning of conference
Managing the organization social Media accounts
Sending Monthly newsletters
Planning of meetings
Scheduled staff or speakers and coordinated facilities to plan logistics for program lectures
Authored reports outlining program accomplishments, statistics, and performance data
Coordinated with marketing team to publish accurate program information on website and other marketing materials
Worked closely with team members to deliver project requirements, develop solutions, and meet deadlines
Prioritized and organized tasks to efficiently accomplish our goals
Demonstrated self-reliance by meeting and exceeding workflow needs
Researched and developed administrative policies, procedures, and guidelines to facilitate operations.
Anti-Aids coordinator
WCDHRI
Nigeria, Nigeria
11.2014 - 12.2014
Induction of Anti-AIDs clubs in secondary schools in the state
Writing report
Monthly visit to schools to coordinate club meetings.
Intern
Institute of Human Virology
Nigeria, Nigeria
11.2012 - 10.2013
Recording of Prevention of Mother to Child Transmission
Health Education and Counseling.
Intern
Live-Well Initiative
Nigeria, Nigeria
07.2011 - 09.2011
My team and I did orientation on various departments and their operations
My team and I were given assignments to get a taxi park, and a mechanic workshop to carry out our community project
I was able to get to the park and the workshop
We did health checkups which include blood pressure, weight, height, and health education was done after the program.
Intern
Ikeja Local Government
Lagos, Nigeria
06.2011 - 07.2011
My team and I did orientation for various department
We were taken to secondary schools where the staff immunized the students
We also witnessed the post-natal activities among women
We coordinated the women for their weighing of babies, checking the health of mothers and appropriate recommendation for health of mothers and babies.
Intern
Ministry Of Health
Lagos, Nigeria
05.2011 - 06.2011
My team and I did orientation on various department
We partook in a community program for secondary school student which are weight measurement, height, rescreening, and Ear flushing.
PSU Sustainability Center Leadership Fellowship at Portland State University Portland ORPSU Sustainability Center Leadership Fellowship at Portland State University Portland OR