Kourtney Drake
Atlanta,GA
Summary
Experienced research professional with 8 years of education in biomedical sciences. Expertise in healthcare and research, including site management, monitoring, specimen collection, data entry, regulatory documentation, site data management, and clinical research coordination. Skilled in conducting blinded and unblinded site monitoring for Phase II and III studies in various therapeutic areas, such as oncology, infectious disease, and rare disease.
Overview
5
5
years of professional experience
Work History
Clinical Research Associate II
ICON
02.2023 - Current
- Monitor investigator sites to ensure studies are carried out according to the study protocol and in accordance with SOPs, applicable regulations, and the principles of ICH-GCP
- Perform site visits from site selection to site close-out in accordance with protocol, GCP/ICH guidelines, and approved monitoring plan
- Documents all captured information from site monitoring visits into detailed trip report
- Ensure all Monitoring Reports, Follow Letters, Confirmations letters are submitted within required timeframe
- Engage in close contact with sites and primary investigator and monitor site compliance
- Identify, select, initiate and close-out appropriate investigational sites for clinical studies
- Maintain and ensure site data quality and adherence to protocol and agreed CMP
- Utilize CTMS to ensure trial activities and visits are up to date
- Maintain essential trial documentation and files documents according to SOP including performing Investigator Site File and Trial Master file Reconciliation
- Maintain and facilitate close contact with sites and primary investigator
- Monitor site progress to identify areas of improvement and assists with site needs in areas such as protocol and study related training , site recruitment and participant retention strategies
- Conduct CRF review, Source data verification, Source data Review
- Oversee and review onsite IP Inventory, storage, and Accountability Records per trial protocol
- Escalates non-compliance, trial misconduct, or any site issue that can interfere with patient safety, data quality or data integrity
- Mentor, train, Evaluate, and sign off fellow employees , resulting in stronger staff development and increased productivity.
Clinical Research Associate I
IQVIA
02.2022 - 02.2023
- Operated as both blinded and unblinded primary CRA on clinical trials
- Engaged in close contact with sites and primary investigator
- Evaluated and ensured site compliance and patient safety within sites
- Maintained and ensured site data quality and adherence to protocol and agreed SOPs
- Complied with study timeline and oversee recruitment progress, data cleaning and appropriate IMP management
- Created, distributed, and maintained all relevant study documentation
- Performed monitoring visits in accordance to monitoring plan and document findings in visit reports
- Reported all SAEs and support site to ensure proper documentation and follow-up
- Conducted CRF review and verification including query issuing and resolution
Clinical Research Coordinator II
ThermoFisher Scientific - Synexus (AES)
Sandy Springs, GA, USA
09.2021 - 01.2022
- Performed as a Coordinator on Phase II & III Clinical research vaccine and pharmaceutical study trials
- Completed, organize, and maintain study regulatory documents and ensure they are compliant with study protocol and ICH-GCP
- Completed case report forms, as well as AE/SAE reporting and documentation
- Managed and schedule patient study visits and adhering to protocol by performing safety and efficacy assessments
- Communicated and reported to study monitors, regulatory authorities, and CRO to ensure data integrity and quality are in accordance with protocol
- Maintained data quality and integrity by providing quality control and assurance to ICF, source data, case report forms, and essential regulatory documents
- Oversaw patient recruitment and compliance with study protocol
- Documented and administer IP per protocol
- Implemented teamwork for various projects and assignments
- Performed specimen collection, processing, and shipping
Lead Clinical Research Coordinator
Wake Research - Mt. Vernon Clinical Research
Sandy Springs, GA, USA
01.2021 - 09.2021
- Performed as lead Coordinator and managed 7 Phase II & III vaccine, device, and pharmaceutical studies simultaneously
- Maintained study regulatory documents such as, drug accountability logs, subject identification logs, site signature logs, screening, and enrollment logs, according to ICH-GCP guidelines
- Created Source documentation for various studies
- Managed patient recruitment and awarded for becoming top 3 enrollment site within 2 months of employment
- Trained new onboarding staff members on study protocols and job duties
- Ensured patients are properly consented per ICH-GCP guidelines and the process is properly documented and maintained
- Provided quality control and assurance procedures to ensure data quality and integrity of ICF, source, case report forms, and other regulatory documents
- Completed case report forms in appropriate EDC, as well as AE/SAE reporting
- Coordinated and participated in pre-site selection visits, site initiation visits, and close out visits
- Maintained site staff certification and ensuring site staff training standards are met per protocol and ICH-GCP guidelines
- Reported to study monitors, regulatory authorities, and sponsors and participate in investigators meetings as required
Clinical Research Assistant
Clinical Research Atlanta
Stockbridge, GA, USA
08.2020 - 01.2021
- Assisted in COVID-19 phase 3 clinical trials by setting up patient trial diaries, monitoring patient compliance according to clinical trial protocols and collecting blood samples and COVID swabs
- Reported and documented AE/SAE according to study protocol
- Conducted patient follow up visits and inputted patient data and visit information into Clinical Trial Management System
- Assisted in preparation for Monitor/CRO site visits/initiations
- Maintained and filed source documents, CRFs and other trial paperwork
- Recruited subjects per protocol specific requirements as well as scheduling visits
Education
Master of Science - Biomedical Sciences
Philadelphia College of Osteopathic Medicine
Suwanee, GABachelor of Science - Biomedical Sciences
Auburn University
Auburn, ALSkills
- ICH/GCP Guidelines
- Excellent Interpersonal and Communication Skills
- AE/SAE Reporting
- Detailed Documentation
- Organization
- Time Management
- Regulatory Compliance and Documentation
- Electronic Data Capture
- Critical Thinking
- Microsoft Office
- Medical Terminology
- Clinical Trial Management System
- Site management
- Case report forms
- Source document verification
- Team Training
- Drug accountability
- Trial Master File Reconciliation
Accomplishments
- ICON Oncology Academy Participant, 2023
Timeline
Clinical Research Associate II
ICON
02.2023 - Current
Clinical Research Associate I
IQVIA
02.2022 - 02.2023
Clinical Research Coordinator II
ThermoFisher Scientific - Synexus (AES)
09.2021 - 01.2022
Lead Clinical Research Coordinator
Wake Research - Mt. Vernon Clinical Research
01.2021 - 09.2021
Clinical Research Assistant
Clinical Research Atlanta
08.2020 - 01.2021
Master of Science - Biomedical Sciences
Philadelphia College of Osteopathic Medicine
Bachelor of Science - Biomedical Sciences
Auburn University