Miya Spicer
Wake Forest,NC
Summary
Highly skilled clinical research professional with a strong track record in coordinating and managing oncology clinical research studies. Proven ability to successfully oversee multiple trials from start to finish, ensuring strict adherence to regulatory guidelines. Exceptional communication skills, enabling effective collaboration with cross-functional teams.
Overview
4
4
years of professional experience
Work History
Clinical Research Coordinator
Institute for Medical Research, Veteran Affairs
03.2024 - Current
- Manage the successful execution of 4 clinical trials during Phase I, II and III, while adhering to regulatory guidelines and achieving enrollment targets of 1,000 to 3,000 participants across multiple sites
- Spearheaded a patient recruitment method, resulting in a 20% increase in enrollment within a 3-month period
- Lead a team of four Research Team Leads, overseeing overall performance and alignment of their respective teams to achieve project aims
- Facilitate clear communication between principal/sub investigators, study sponsors, and other study personnel to discuss study progress, logistics and metrics, maintaining project goals and objectives
- Prepare study documents in collaboration with the regulatory affairs team, for the Institutional Review Board (IRB) submission and review
- Create and maintain investigator site files (ISFs)/regulatory binders, delegation of authority logs and source document worksheets
Research Team Lead
Institute for Medical Research, Veteran Affairs
01.2023 - 03.2024
- Supervised a team of 6 Data Technicians, effectively delegating tasks and regularly tracking performance metrics to identify bottlenecks, consistently achieving productivity rate of 96% across all projects
- Lead screening and abstraction trainings for multiple projects and created, maintained, and modified SOPs, reference guides and additional training materials
- Analyzed data abstracted into EDC and Clinical trial management systems & resolve queries, ensuring data quality and reducing data entry errors by 25%
- Assist with study monitoring visits and site audits in compliance with ICH/GCP and FDA regulations
Clinical Trial Assistant
Institute for Medical Research, Veteran Affairs
05.2022 - 01.2023
- Successfully conducted thorough patient screening of 70+ patients per week including medical history review and eligibility criteria assessment, achieving a 100% productivity rate
- Recruited 15-20 patients per week for participation in clinical trials by providing details of study protocols, risks, benefits and obtaining informed consent documents
- Performed clinical data abstraction utilizing Clinical Trial Management Systems (CTMS) and working in compliance with study protocols and SOPs
- Central contact for the clinical team for designated project communications, study metrics, study correspondence, and associated documentation
Encoder
DHL ECommerce
11.2020 - 02.2022
- Verified the accuracy of entered data, ensuring high-quality of information
- Maintained optimal productivity by processing over 660 pieces per hour, achieving a 100% efficiency rate
- Enhanced team performance by auditing the work of other Encoders to prevent errors and optimize task distribution
Education
Bachelor of Science - Liberal Studies
North Carolina A&T State University
Greensboro, NC05.2018
Skills
- Oncology Clinical Research
- Cross Functional Team Collaboration
- IRB Submissions
- Data Query Management
- Quality Assurance
- Strong Presentation Skills
- Good Clinical Practice
- Risk Management
- SOP & Protocol Development
- Clinical Data Management
- Veeva Vault
- Medidata CTMS
- Clario/ Bioclinica
- OpenClinica
- Jira
- Microsoft Suite: PowerBI, Excel, Word, PowerPoint
Certifications
- Privacy and HIPAA - Veteran Affairs Training Management System (TMS), 2023
- Healthcare Clinical Research - Wake Technical Community College, 2022
- Good Clinical Practice (GCP) US FDA focus - CITI Program, 2022
- Veteran Affairs Human Subjects Protection - CITI Program, 2022
Timeline
Clinical Research Coordinator
Institute for Medical Research, Veteran Affairs
03.2024 - Current
Research Team Lead
Institute for Medical Research, Veteran Affairs
01.2023 - 03.2024
Clinical Trial Assistant
Institute for Medical Research, Veteran Affairs
05.2022 - 01.2023
Encoder
DHL ECommerce
11.2020 - 02.2022
Bachelor of Science - Liberal Studies
North Carolina A&T State University
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