Yorde ONNE
Atlanta,GA
Summary
Detail-oriented individual with exceptional communication and project management skills. Possesses a proven ability to handle multiple tasks effectively and efficiently in fast-paced environments. Recognized for proactive approach to identifying and addressing issues, always focusing on optimizing processes and supporting team objectives. Clinical research professional with a solid foundation in managing complex clinical trials and ensuring regulatory compliance. Expertise lies in fostering collaborative team environments and driving successful project outcomes. Reliable and adaptable, always striving to achieve results and maintain high standards.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Highly Skilled Senior Clinical Research Associate
Parexel
02.2020 - 03.2025
- With extensive years of experience in Phase I-IV clinical trials across multiple therapeutic areas
- Adept at site monitoring, regulatory compliance (ICH-GCP, FDA, EMA), risk-based monitoring (RBM), and team leadership
- Proven track record in ensuring data integrity, patient safety, and operational efficiency in global clinical trials
- Key Strengths Good Clinical Practice (GCP) & regulatory compliance Clinical trial monitoring & site management Protocol adherence & risk-based monitoring (RBM) Electronic Data Capture (EDC) & CTMS platforms Investigator & site training Adverse event (AE) & serious adverse event (SAE) reporting Vendor & sponsor communication Cross-functional team collaboration
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Supported regulatory submissions with comprehensive documentation preparation, leading to successful approval of investigational products.
- Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
- Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
Clinical Research Associate II
Parexel
03.2017 - 02.2020
- Conduct Field Evaluation Visits and field training for CRA Is, IIs and other Senior CRA
- Serve as mentor for junior CRA and those new to the company and/or study
- Perform site evaluation visits of potential investigators
- Evaluate the capability of the site to successfully manage and conduct the clinical study
- Collaborate activities with the site in preparation for the initiation of the study
- Obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials
- Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provide training on completion of the eCRF monitoring activities and study close-out activities
- Train site staff on the EDC system and verified site computer system
- Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits
- Perform validation of source documentation as required by sponsor
- Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor
- Key Achievements: Reduced protocol deviations by 95% through proactive site engagement and training
- Successfully led 2 site audits with zero critical findings
- Spearheaded the implementation of risk-based monitoring in a breast cancer Ph III trial, improving data accuracy by 100%
- Assisted with data quality, CRF guideline development, and ongoing clinical data review
- Proficient in performing manual, in-house review of CRF data for completeness and accuracy and resolving data management and data query issues with study sites and CRAs
- Collaborated with team to maintain consistent CRF data quality and discrepancy resolution across sites
- Assisted in development of study tools and guidelines to be utilized by study site
- Assisted in the potential investigators and sites selection process
- When monitoring independently, I will write monitoring reports per SOPs
- Communicates with sites and vendors and maintains effective management of study issues
- Conducted site visits (pre-study, initiation, interim and close-out)
- Reviewed site's informed consents against the consent template for presence of GCP requirements, protocol specific information and for accuracy
- Proficiently coordinated and reviewed regulatory documents from study sites to ensure completeness, accuracy, and compliance at the site and in the Trial Master File (TMF)
- Assisted with sites and vendors issues and corrective action prevention plan resolutions
- Co-monitored with CRAs to assist with on-site monitoring and study visit training as needed.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
- Participated in the review of clinical trial data during preparation of final study reports, highlighting key findings for further analysis or publication purposes.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
Clinical Research Associate
I • Parexel
01.2015 - 03.2017
- Managed and monitored all aspects of clinical trials in accordance with study protocol, SOPs, ICH and GCP guidelines for clinical trials
- Responsible for site selection and study monitoring
- Ensured site compliance to drug safety and regulatory affairs
- Investigated and completed reports on patient safety and site safety issues
- Instructed sites on how to document and report AE, SAE and safety concerns
- Attended study start-up meetings
- Conducted source data verification
- Performed phone screen interviews for identified trial sites
- Assisted in trial site selection
- Make sure regulatory binders are up to date
- Ensured site is ensuring patient safety by adhering to protocol and abiding by the inclusion and exclusion criteria for each trial
- Ensured that written informed consent is obtained appropriately and prior to any procedures
- Write and submitted visit reports in a timely manner
- Acted as liaison between Sponsor and site
- Ensured that Principal Investigator and site staff are conducting the study per protocol guidelines.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
- Managed multiple clinical sites simultaneously while maintaining a high level of attention to detail and meeting deadlines.
- Participated in the review of clinical trial data during preparation of final study reports, highlighting key findings for further analysis or publication purposes.
- Assisted in the preparation of regulatory submissions, supporting successful approval for clinical trials.
- Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
Research Study Coordinator
EMORY UNIVERSITY HOSPITAL
01.2014 - 01.2015
- Maintained proper filing of the essential regulatory documents and pharmacy binder of the clinical trial site
- Created source documents to ensure accurate data collection throughout the length of the study
- Recruiting, screening and enrolling patients in clinical trials
- Assisted in the submission of proposals involving research and human subjects (complete required forms) for IRB approval
- Dispensed and collected study drugs per protocol as well as maintaining a precise inventory on medications (on the pharmacy binder)
- Attended Site Initiation Visits (SIVs) for upcoming studies to gather the appropriate background knowledge
- Input data in Electronic Data Entry (EDC) programs as well as rectify queries
- Maintained Case Report Form (CRF) logs
- Compiled and added pertinent information to subject study charts to document each visit
- Scheduled appointments and made reminder call to comply with study specific dates
- Conducted general study related tasks during subject visits: EKGs, Phlebotomy, Vital signs, and collect Adverse Event
- Laboratory procedures such as centrifuging, pipetting and filling out requisition forms per protocol
- Ensured that every subject was adequately informed and consented to the study before any study procedures were completed.
- Organized regular team meetings for efficient coordination among colleagues leading to improved collaboration.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Evaluated potential risks associated with each study proactively addressing any concerns or issues before they arose.
- Prepared detailed progress reports to keep stakeholders informed of study milestones and accomplishments.
- Coordinated logistical aspects of research projects, including scheduling appointments, organizing meetings and managing budgets.
Education
Project Management Certificate - Project Management
Emory University
Atlanta, GA06.2022
Bachelor of Science - Sociology and Anthropology
O.A.U
2001
Skills
- Data management proficiency
- Management of Site Operations
- Informed consent process
- Adverse event reporting
- Report writing
- ICH-GCP Expertise
- Electronic data capture systems
- Site Monitoring visits expertise
- Study protocols
- Research sops understanding
- Time management abilities
- Risk assessment
- Leadership skills
Certification
TECHNICAL SKILLS CITI Program Good Clinical Practice (GCP) Certification – 2025 Certificate in Project Management Emory University Atlanta, 2022 Project Management Institute | Member ID 7305412 Clinical Trial Systems: iMedidata, RAVE, Veeva Vault, Oracle Inform Regulatory Compliance: ICH-GCP, FDA, EMA, MHRA Documentation & Reporting: CTMS, eTMF, EDC, SAE reporting LANGUAGE English Language (Fluency)
Languages
English
Native or Bilingual
Timeline
Highly Skilled Senior Clinical Research Associate
Parexel
02.2020 - 03.2025
Clinical Research Associate II
Parexel
03.2017 - 02.2020
Clinical Research Associate
I • Parexel
01.2015 - 03.2017
Research Study Coordinator
EMORY UNIVERSITY HOSPITAL
01.2014 - 01.2015
Project Management Certificate - Project Management
Emory University
Bachelor of Science - Sociology and Anthropology
O.A.U
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