Summary
Overview
Work History
Education
Skills
References
Timeline
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Brittany Wortham

Greensboro/Winston-Salem/RDU,NC

Summary

Experienced Clinical Research Coordinator with 4 years of background in clinical research, trial design, and research data management. Currently working at Atrium Health Wake Forest Baptist hospital focusing on patient care and driving research initiatives. Holds a recently acquired Master's in Medical Sciences from the University of Florida, with a passion for healthcare in underserved communities. Skilled in EMR and EDC systems, ICH/GCP guidelines, and SOPs, known for strong communication, adaptability, and time management abilities.

Overview

4
4
years of professional experience

Work History

Clinical Research Coordinator

Atrium Health Wake Forest Baptist
Winston-Salem, NC
02.2023 - Current
  • Engaged in the initiation, execution, and conclusion of COVID and HIV Phase 2-4 clinical studies, while supporting IRB and regulatory obligations through recruitment material preparation and document management
  • Managed primary coordination duties for eight studies involving COVID, HIV, and pneumonia, overseeing informed consent, data collection, CRF completion, and participant visit reconciliation
  • Acted as a backup coordinator for seven additional studies, providing leadership continuity during absences and performing phlebotomy tasks
  • Facilitated efficient study visits by ensuring daily care for participants, conducting necessary procedures, and organizing monitoring visits
  • Contributed to financial tasks for three study start-ups using OnCore, ClinCard, and EPIC databases, while incorporating data analysis techniques to enhance study outcomes.

Research Analyst I

Duke Human Vaccine Institute
Durham, NC
08.2022 - 02.2023
  • Contributed to clinical research trial operations by conducting diverse investigations to plan, develop, and execute experimental procedures like cryopreservation, leukopheresis, and rt-PCR
  • Utilized specialized laboratory techniques to analyze materials, prepare reports, monitor trends, and draw appropriate conclusions
  • Collaborated in creating Standard Operating Procedures (SOPs) for laboratory management and testing protocols related to COVID and HIV research
  • Led the redevelopment of the Laboratory Data Management System (LDMS) overseeing thousands of HIV plasma productions stored in -80 freezers.

Research Technician II

Duke Human Vaccine Institute
Durham, NC
05.2021 - 08.2022
  • Contributed to clinical research trials by conducting assays and evaluating virus-specific responses related to HIV, while processing numerous human specimens for Sars-COV-2 virological testing, using rt-PCR, catering to the needs of Duke's faculty, staff, and students
  • Ensured laboratory safety and quality standards in compliance with Good Clinical Laboratory Practices (GCLP)
  • Supported senior management by developing and refining testing protocols to enhance efficiency and effectiveness in testing procedures.

Lab Technologist/PCR Scientist

Duke Human Vaccine Institute
Durham, NC
10.2020 - 05.2021
  • Facilitated the testing of a large volume of samples for Sars-COV-2 received from Duke Hospital and the surrounding Durham population to advance clinical research efforts
  • Conducted mandatory Covid-19 rapid tests, employing appropriate swabbing techniques to collect specimens accurately
  • Implemented stringent in-process quality control measures and meticulously recorded patient data for precise specimen preparation, testing, and subsequent analysis.

Molecular Lab Technician

Mako Medical Laboratories
Henderson, NC
05.2020 - 10.2020
  • Conducted a significant number of rt-PCR tests during the rapid escalation of Sars-COV-2 transmission to support the progress of clinical research initiatives
  • Adhered to standardized operating procedures (SOPs), managed the reception and processing of test samples, and executed DNA/RNA extraction, quantification, and gel quality control assessments
  • Executed qPCR, clean up procedures, DNA sequencing, and data analysis, while utilizing a Laboratory Information Management System (LIMS) to manage Sars-COV-2 patient data and test outcomes efficiently
  • Selected as a key team member responsible for training new staff in diverse laboratory methodologies and the upkeep and operation of equipment crucial for Sars-COV-2 testing.

Education

Masters of Medicine in Medical Physiology and Pharmacology -

University of Florida
08.2023

Bachelor of Science in Biology and Chemistry -

Campbell University
05.2020

Skills

  • CLIA/CAP Guidelines
  • Clinical monitoring
  • Patient care
  • Medical chart review
  • Phlebotomy
  • Microsoft Applications
  • EDC: REDCAP, Medidata, OmniComm Trial Master, Clario
  • Project Monitoring
  • Good Clinical Practice
  • Integrated Medical Reporting
  • Data Evaluation
  • Protocols Development
  • Monitoring Visits
  • Detailed Documentation
  • Site Management

References

  • Salvatore Scianna, Senior Research Analyst, DHVI, Salvatore.scianna@duke.edu
  • Jerry Peters, Research Analyst II, DHVI, jerry.peters@duke.edu
  • Carmela Archual, Research Analyst II, DHVI, carmela.archual@duke.edu

Timeline

Clinical Research Coordinator

Atrium Health Wake Forest Baptist
02.2023 - Current

Research Analyst I

Duke Human Vaccine Institute
08.2022 - 02.2023

Research Technician II

Duke Human Vaccine Institute
05.2021 - 08.2022

Lab Technologist/PCR Scientist

Duke Human Vaccine Institute
10.2020 - 05.2021

Molecular Lab Technician

Mako Medical Laboratories
05.2020 - 10.2020

Masters of Medicine in Medical Physiology and Pharmacology -

University of Florida

Bachelor of Science in Biology and Chemistry -

Campbell University
Brittany Wortham