Summary
Overview
Work History
Education
Skills
Timeline
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Barbara Larson

Cleveland,United States

Summary

Clinical Researcher with 10 years of progressive experience conducting research to study human diseases and drive healthcare improvements. Investigative professional leading clinical research to support diagnosis and treatment of diseases. Critical thinker with background developing and improving methodologies and procedures for superior data analysis and reporting.

Overview

11
11
years of professional experience

Work History

Clinical Research Associate

Alume Biosciences
04.2024 - Current
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Created and maintained database and records filing system to document data on specimen collection, processing and storage.
  • Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
  • Assisted in development, review and revision of standard operating policies and procedures in collaboration with senior management.
  • Spearheaded and implemented new projects to expand scope of engagement.

Compliance Monitor

The Clinical Trials Network
06.2023 - 03.2024
  • Responsible for managing the audit program, pre-audit planning, leading the audit, and following up internally and externally to get findings efficiently and effectively resolved.
  • Composing the summary audit reports and effectively communicating the findings and observations to leadership.
  • Trained new sites on GCP, compliance, and ALCOA, including investigator training for study startup.
  • Performed on-site and remote audits as a quality assurance tool that is used to evaluate compliance and to ensure human subject protection and data integrity.
  • Completed protocol deviation reporting to all internal review boards centrally and locally while adhering to reporting guidelines.
  • Maintained an in-depth knowledge of regulations impacting clinical research.
  • Work with study teams to formulate Corrective and Preventive Action Plans (CAPAs) based on audit findings.
  • Tracked assigned research projects utilizing a risk-based assessment tool to prioritize research studies for in-depth review.

Clinical Research Specialist

University Hospitals
02.2020 - 06.2023
  • Managed and coordinated 15+ clinical trials, ensuring compliance with FDA regulations, which led to a 20% increase in trial efficiency and a 15% improvement in patient enrollment rates.
  • Gathered and evaluated quality assurance data to identify issues and improve process efficiency.
  • Trained and mentored new staff to achieve efficiency and maintain daily operational consistency.
  • Designed, constructed and implemented research proposals, protocols and procedures.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.

Research Associate

The Ohio State University
01.2015 - 07.2018
  • Conducted research and analysis for projects related to epigenetics, and creating genomic libraries.
  • Initiated new study protocols for DNA extraction and purification to isolate rmr12-2 mutant alleles.
  • Performed laboratory research on the effects of Paramutation in maize, to determine the modes of transgenerational epigenetic inheritance.
  • Collected data from experiments performed by others under supervision and analyzed results using statistical methods to determine significance when applicable.
  • Utilized software programs such as MATLAB and R to analyze data received to create visualizations.

Education

Bachelors of Science - Health Science

Cleveland State University
01.2019

Skills

  • Audit preparation
  • Document review
  • Clinical monitoring
  • Feasibility analysis
  • Patient recruitment
  • Regulatory submissions
  • Trial oversight

Timeline

Clinical Research Associate

Alume Biosciences
04.2024 - Current

Compliance Monitor

The Clinical Trials Network
06.2023 - 03.2024

Clinical Research Specialist

University Hospitals
02.2020 - 06.2023

Research Associate

The Ohio State University
01.2015 - 07.2018

Bachelors of Science - Health Science

Cleveland State University

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