Yvonne Angela Kimende
Lenexa,KS
Summary
Versatile clinical research professional knowledgeable in coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. A detail-oriented team player with strong organizational and problem solving skills with the ability to handle multiple projects simultaneously while ensuring a high degree of accuracy.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Trial Associate
Drug Farm
08.2022 - 02.2023
- Interacted directly with internal study cross functional leads and vendors to provide support in project-specific tasks and the overall management of clinical trials
- Provided support to the clinical team with preparation, handling, distribution, filing and archiving of clinical documents and reports according to applicable Standard Operating Procedures and ICG/GCP guidelines
- Accountable for periodic quarterly review of departmental and study files for completeness, ensured accuracy and consistency throughout the study
- Acted as a central contact for the clinical team for designated project communications, correspondence and associated documents (e.g., update study team and vendor contact information)
- Accountable for the planning, organizing and execution of study-specific meetings and distributed agendas and minutes with the ability to plan, prioritize resources needed to accomplish tasks
- Ensured the project team maintained consistent through training materials, maintained GCP compliance and inspection readiness throughout study conduct
- Intermediate level knowledge of GCP, ICH guidelines and clinical trial conduct practices.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
Project Associate
ICON PLC
11.2020 - 04.2022
- Maintained open communication proactively with both internal and external stakeholders by presenting regular updates on project status.
- Monitored project progress, identified risks and took corrective action as needed.
- Set up and managed weekly team meetings, agendas and distribution of minutes.
- Accountable for the eTMF quality and accuracy throughout study conduct and provided support during client and Quality Assurance audits regarding the processes and content of the Trial Master File
- Managed study specific Project portals and software such as Salesforce (PSO), SharePoint, Box including setup, maintenance, and external user access
- Cross collaborated between different teams within different geographical areas while respecting cultural differences
- Provided support to the Project Manager to deliver excellence and strategic leadership with different stakeholders throughout the project
- Responsible for Internal training of different cross- functional teams via learning management systems in accordance with SOPs and policies holding team members accountable for completing in a timely manner
- Achieved project quality by identifying quality risks and issues raised by project team members
- Intermediate level Knowledge and understanding of ICH, GCP and applicable local regulatory requirements.
Clinical Research Nurse
PRA Health Sciences, ICON PLC
08.2019 - 12.2020
- Coordinated and participated in phase 1 clinical research studies ensuring that studies are carried out according to protocol and applicable guidelines and regulations
- Provided safety monitoring and supervision of study participants
- Ensured proper documentation while paying attention to detail and accuracy to meet all reporting requirements
- Responsible for ensuring data collected on study volunteers adhered to study protocols
- Assisted in screening of volunteers for inclusion in study based on pre-determined criteria
- Reviewed informed consents with study participants and explained procedures and practical issues such as timelines for visits and restrictions on food or drinks as required
- Entered clinical data into the electronic data systems
- Collaborated closely with study investigators on adverse events (AE) according to procedures outlined in the protocol
- Participated in project meetings with sponsors and other members of the project team as needed
- Coordinated and assisted with study preparations, source documentation, recruitment and all study related procedures.
Licensed Practical Nurse
Maxim Health Services
10.2017 - 06.2020
- Took and recorded vital signs such as blood pressure, pulse and respiration, noting any undesirable signs and reporting them to other medical members
- Monitored pediatric patients and completed charting of medical records accurately in the comfort of their homes
- Communicated openly and effectively with patients and families, while demonstrating compassion and friendly behavior
- Ensured that supplies, medications, and equipment are restocked so that they are ready to use
- Distributed correct medications to patients in proper doses, recording times of administration in charts to ensure ongoing accuracy.
Licensed Practical Nurse
Brookdale
07.2016 - 06.2020
- Identified patient care requirements by establishing personal rapport with patients and families
- Assured quality of care by adhering to therapeutic standards, measuring health outcomes against patient care goals and hospital
- Protected patient information by adhering to therapeutic standards; measuring health outcomes against patient care goals and hospital or regulatory standards
- Documented patient care services by chart in patient and department records
- Captured electronic medical records into the clinical systems as required
- Maintained nursing supplies inventory by checking stock to determine inventory level
- Maintained a cooperative relationship among health care teams by communicating information and participating in team problem-solving methods
- Administered medications and rendered treatment to patients
- Collaborated with physicians to create a plan of care for each patient
- Responded to inquiries, concerns and complaints from patients and their parents or guardians.
- Monitored, tracked, and conveyed important patient information to healthcare staff to help optimize treatment planning and care delivery.
Education
Bachelor of Arts - Public Relations and Broadcast Journalism
Daystar University
Nairobi, Kenya06.2010
No Degree - LICENSED PRACTICAL NURSE
Kansas City Kansas Community College
Kansas City, KS05.2016
Skills
- Microsoft Office, Veeva Vault TMF, BOX, PSO (Salesforce), Medidata Rave
- Strong written and verbal communication skills
- Ability to plan, prioritize and provide result oriented tasks
- Strong problem solving skills
- Attention to detail and accuracy
- FDA Compliance and Good Clinical Practice
- Therapeutic Areas: Neurology/Parkinson's Disease, Infectious Diseases/Hepatitis, Psychiatry/Schizophrenia, Oncology/Multiple Solid Tumors
Certification
Licensed Practical Nurse, Certified Medication Aide.
Certificate: Implementation and Support Specialist
Certificate: Certified Scrum Master
Timeline
Clinical Trial Associate
Drug Farm
08.2022 - 02.2023
Project Associate
ICON PLC
11.2020 - 04.2022
Clinical Research Nurse
PRA Health Sciences, ICON PLC
08.2019 - 12.2020
Licensed Practical Nurse
Maxim Health Services
10.2017 - 06.2020
Licensed Practical Nurse
Brookdale
07.2016 - 06.2020
Bachelor of Arts - Public Relations and Broadcast Journalism
Daystar University
No Degree - LICENSED PRACTICAL NURSE
Kansas City Kansas Community College
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