WHITNEY A. DAVIS
Chicago,IL
Summary
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities.
Overview
4
4
years of professional experience
Work History
Clinical Research Associate 1
IQVIA Biotech
10.2022 - Current
- Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
- Establish regular lines of communication plus administering protocol and related study training to assigned sites.
- Evaluates the quality and integrity of site practices – escalating quality issues as appropriate.
- Manages the progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Monitors safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Follows drug storage procedures to comply with protocols and SOP requirements.
Clinical Research Coordinator II
UChicago Medicine Cellular Therapy Program
07.2022 - 11.2022
- Coordinated and managed multiple phase I, II, and III Hem/Onc trials (PI-initiated, industry-sponsored).
- Managed three different protocols with at least two active patients.
- Coordinated the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
- Collected, processed, shipped, and stored specimens to appropriate laboratory according to established aseptic techniques.
- Educated patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
Clinical Research Data Manager II
University of Chicago Comprehensive Cancer Center Biological Sciences
09.2021 - 07.2022
- Prepared and maintained clinical research charts for each patient while validating research results accurately through protocols and study-related documentation.
- Managed data for seven different protocols with at least four active subjects each.
- Created departmental processes for auditing assigned projects and generated required research documentation.
- Spearheaded clinical trial documentation using objective tools to operate and navigate clinical trial systems.
- Oversaw day-to-day clinical operations and managed communication pipelines across cross-functional teams.
Emergency Department Medical Scribe
ScribeAmerica For Ingalls Memorial Hospital
05.2019 - 07.2020
- Recorded confidential patient information regarding visits, procedures, and tests for doctors' review.
- Reported medical history of over 50 patients per day; records including CC, HPI, PMHx, and PSurgHx.
- Decreased patient waiting time through providing excellent organizational skills.
- Assisted physicians in accessing all relevant test results.
- Followed all HIPAA rules and regulations regarding patient confidentiality.
- Documented complete information about examinations, treatment plans, lab results and other details directly into charts.
Education
Master of Science - Health Communication
NORTHWESTERN UNIVERSITY
Chicago, IL08.2021
Bachelor of Science - Biology
HOWARD UNIVERSITY
Washington, DC05.2019
Skills
- EPIC System
- iMedidata Rave System
- Medrio System
- Project Management
- EMR (Electronic Medical Records)
- EDC (Electronic Data Capture)
- SOP (Standard Operating Procedure)
- Protocols
- AE and SAE reporting
- Data Evaluation
- Data Collection
- Patient Safety
- Team Training
- Status Reporting
- Monitoring Visits
Therapeutic Summary
I have been working in Clinical Research since 2021. I became a Clinical Research Associate (CRA) in 2022 when she joined IQVIA Biotech. As a CRA, I conduct monitoring visits for assigned protocols and study sites. I ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures, good clinical practice and applicable regulatory requirements. Prior to joining IQVIA Biotech, I worked as a Clinical Research Coordinator as well as a Clinical Research Data Manager at University of Chicago working with Principle Investigators in the implementation of industry sponsored phase I-III clinical trials.
Therapeutic Area Experience Summary: Hematology/Oncology (2 years):
Solid Tumor Phase I-II (2), Graft Versus Host Disease Phase I (2), Multiple Myeloma CAR-T Phase I-II (2), Leukemia CAR-T Phase 1 (2), Leukemia Phase 1 (2), Lymphoma Phase I (2), Thrombocytopenic Disorder Phase III (2)
Licenses and Certificates
- IQVIA Fundamental GCP Accreditation Exam, , 2022
- IATA Shipping Dangerous Goods, 2021
- CITI Good Clinical Practice Course, 2021
- CITI Biomedical Faculty/Investigators, Research Staff, or Administration Staff, 2021
Awards and Honors
- Dean's List, 2021
- Dean's List, 2020
Timeline
Clinical Research Associate 1
IQVIA Biotech
10.2022 - Current
Clinical Research Coordinator II
UChicago Medicine Cellular Therapy Program
07.2022 - 11.2022
Clinical Research Data Manager II
University of Chicago Comprehensive Cancer Center Biological Sciences
09.2021 - 07.2022
Emergency Department Medical Scribe
ScribeAmerica For Ingalls Memorial Hospital
05.2019 - 07.2020
Master of Science - Health Communication
NORTHWESTERN UNIVERSITY
Bachelor of Science - Biology
HOWARD UNIVERSITY
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