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Isadora Penhallow-Kyei

Junior Clinical Data Coordinator
Omaha, NE, United States

Professional Summary

Detail-driven junior clinical data coordinator with 3+ years of experience supporting Phase I–III oncology, cardiology and metabolic trials across academic and CRO settings. Skilled in EDC data entry and query resolution in Medidata Rave and REDCap, CRF reconciliation, SAE tracking and source data verification support under ICH-GCP and 21 CFR Part 11. Processes roughly 2,400 CRFs per quarter and cut average query turnaround from 6 to 3 days through structured tracking and proactive site follow-up. Known for clean audit trails, calm communication with site staff and monitors, and a steady drive to make trial data inspection-ready.

Employment History

Clinical Data Coordinator
Midlands Clinical Research Partners · Omaha, NE
Jun, 2024 · Present
Enter and clean subject data in Medidata Rave and REDCap EDC for 4 concurrent Phase II–III studies, processing ~2,400 CRFs per quarter with a 99.2% first-pass accuracy rate Resolve data queries with site coordinators and monitors, cutting average query turnaround from 6 to 3 days via a shared aging tracker and weekly follow-up cadence Reconcile CRFs against source documents and lab transfers, closing 1,100+ discrepancies ahead of 3 interim database locks Track and reconcile 85+ serious adverse events (SAEs) between the safety database and EDC, ensuring 100% were reported within regulatory timelines Support source data verification visits by preparing subject binders and SDV listings, helping monitors complete 30% more SDV per visit Maintain 21 CFR Part 11–compliant audit trails and eTMF filings in Veeva Vault, with zero critical findings in a 2025 sponsor audit
Clinical Research Assistant
Heartland Health Research Institute · Omaha, NE
Jan, 2023 · May, 2024
Coordinated day-to-day data collection for 3 cardiology and metabolic studies enrolling 260+ participants across 2 clinic sites Built and maintained 14 REDCap instruments with branching logic and validation rules, reducing out-of-range entries by 40% Prepared regulatory binders, delegation logs and IRB continuing-review packets, achieving 100% on-time submissions Performed first-line source data verification on 1,500+ visit records, flagging protocol deviations to the PI within 24 hours Scheduled and consented participants, maintaining 92% visit retention across 18-month follow-up windows
Research Data Intern
University of Nebraska Medical Center, Pharmacology Lab · Omaha, NE
May, 2022 · Dec, 2022
Cleaned and merged 3 years of preclinical assay datasets (45,000+ rows) in Excel and SQL for a manuscript submission Built pivot-table dashboards that cut weekly lab reporting time from 4 hours to 1 hour Wrote basic SAS programs to generate summary statistics and listings for 2 internal data reviews Documented a data dictionary and file-naming SOP adopted by 9 lab members

Education

B.S. Biology
University of Nebraska Omaha · Omaha, NE
Aug, 2018 · May, 2022
GPA 3.7/4.0. Relevant coursework: Biostatistics, Clinical Research Methods, Human Physiology, Pharmacology, Database Fundamentals.

Skills

Medidata Rave
REDCap
Veeva Vault
ICH-GCP
21 CFR Part 11
MedDRA coding basics
Excel pivot tables
SQL basics
Query management
CRF reconciliation
SAE tracking
SAS basics

Courses

CITI Good Clinical Practice (GCP) Certification
CITI Program
Completed 2023; renewed 2025. ICH E6(R2) GCP for clinical trials with investigational drugs.
ACRP Certified Professional (ACRP-CP) — In Progress
Association of Clinical Research Professionals
Exam preparation underway; target sitting in 2027.
Human Subjects Research (HSR) — Biomedical
CITI Program
Completed 2022.