Brittany Myles
Katy
Summary
Detail-oriented and certified Clinical Research Associate (CRA) monitoring clinical trials, ensuring regulatory compliance, and maintaining Good Clinical Practice (GCP) standards. Proven ability to manage multiple sites, assess data accuracy, and collaborate with cross-functional teams to ensure study success. Passionate about advancing medical research while prioritizing patient safety and protocol adherence.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
IQVIA
07.2022 - Current
- Monitored [X+] clinical trial sites, ensuring compliance with ICH-GCP, FDA, and IRB regulations
- Conducted site selection, initiation, routine monitoring, and close-out visits
- Reviewed and verified Case Report Forms (CRFs) for accuracy and completeness
- Ensured timely reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Collaborated with Principal Investigators (PIs) and site coordinators to resolve protocol deviations
- Assisted in the preparation of regulatory submissions and maintained Trial Master File (TMF)
- Provided training to study teams on clinical trial protocols and compliance requirements
Clinical Research Coordinator
Tulane University
02.2018 - 06.2022
- Assisted in subject recruitment, informed consent process, and study enrollment
- Collected, entered, and maintained study data in compliance with regulatory requirements
- Coordinated site visits, audits, and sponsor interactions
- Ensured investigational product accountability and adherence to study protocols
Education
Bachelor - Science
Xavier University of Louisiana
New Orleans, LA05.2013
Skills
- Clinical Trial Monitoring & Site Management
- Good Clinical Practice (GCP) Compliance
- Regulatory Submissions & Documentation
- Protocol & SOP Adherence
- Risk-Based Monitoring (RBM)
- Data Analysis & Quality Assurance
- Investigator & Site Training
- Patient Recruitment & Retention
- Adverse Event (AE) & Serious Adverse Event (SAE) Reporting
- Electronic Data Capture (EDC) Systems
- Clinical Trial Management Systems (CTMS)
- Microsoft Office Suite
Websites
Certification
- Good Clinical Practice (GCP) Certification
- Human Subjects Research Training (e.g., CITI Program)
Affiliations
- Association of Clinical Research Professionals (ACRP)
- Society of Clinical Research Associates (SOCRA)
Timeline
Clinical Research Associate
IQVIA
07.2022 - Current
Clinical Research Coordinator
Tulane University
02.2018 - 06.2022
Bachelor - Science
Xavier University of Louisiana
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