Summary
Overview
Work History
Education
Skills
Licenses
Certification
Timeline
Generic

Nataly Madrid

Los Angeles,CA

Summary

Well-organized and diligent Regulatory Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering over seven years of experience in the pharmaceutical research industry. Currently seeking to grow in a challenging new role.

Overview

6
6
years of professional experience
1
1
Certification

Work History

Regulatory Specialist, II

Velocity Clinical Research
10.2021 - Current
  • Streamlined regulatory submission processes for increased efficiency and reduced approval timeframes.
  • Maintain electronic Investigator Site Files via the Advarra eRegulatory platform and adhere to policies and procedures
  • Work alongside Study Sponsors and Clinical Research Organizations for the duration of the trial for scheduled monitoring visits and Sponsor audits
  • Perform quality checks on investigator site files to ensure compliance and audit readiness
  • Archiving of Investigator Site Files based on site needs
  • Perform Study Data Archival at the end of the trial
  • Follow-up as needed for Clinical Trial Documents and required staff training or review documentation for Protocol and Protocol Amendments/Addendums, Protocol Clarification LettersChanges to Informed Consent Forms, IND Safety Reports, Investigator Brochures
  • Submit annual continuing review reports and termination reports to Central IRB.
  • Managed complex regulatory projects, ensuring timely completion and optimal outcomes.
  • Optimized internal audit processes, identifying areas for improvement in regulatory adherence.


Regulatory Coordinator

National Research Institute
08.2018 - 10.2021
  • Manage and oversee all regulatory start-up activity including IRB submission and Regulatory Package to ensure prompt study start-up and approval
  • Supervise and provide mentorship to Regulatory Associates
  • Participate in clinical operations meetings weekly
  • Provide clear, concise, and timely updates on regulatory start-up activities
  • Proactively identify potential regulatory delays or issues with start-up
  • Provide positive and professional communication with sponsors, monitors, and IRBs
  • Oversee annual development and renewal of NRI SOPs in coordination with management
  • Provide Quality Checks on Study Regulatory Binders and ICFs
  • Develop and maintain a shared Trial Master File system that is to be accessed and shared with the Regulatory team
  • Follow-up with numerous issues concerning clinical trials: Protocols, Amendments, Addendums, and Clarification Letters; Changes to Informed Consent Forms; IND Safety Reports; Protocol Deviations and Serious Adverse Events.
  • Conducted internal audits to identify areas of improvement and ensured corrective actions were implemented.

Administrative Assistant

National Research Institute
10.2021 - Current
  • Executed record filing system to improve document organization and management
  • Answered multi-line phone system, routing calls, delivering messages to staff, and greeting visitors
  • Edited documents to improve the accuracy of language, flow, and readability
  • Conducted onboarding to help new hires adjust to administrative performance aspects of jobs
  • Set up conference rooms, technology, and materials to facilitate meetings
  • Scheduled office meetings and client appointments for staff teams
  • Monitored office calendars to plan meetings, activities, and travel to maximize productivity
  • Scheduled office meetings and client appointments for staff teams
  • Screened visitors and issued badges to maintain safety and security
  • Scheduled conference rooms, prepared agendas, and maintained calendars to prepare for events
  • Received and sorted incoming mail and packages to record, dispatch, or distribute to the correct recipient
  • Offered technical support and troubleshooting issues
  • Interacted with vendors to purchase and set up equipment and services
  • Scheduled office equipment repair and maintenance to extend equipment lifespan and prevent unplanned downtime.

Education

Esthetician Certification -

Victory Career College
Torrance, CA

High School Diploma -

Los Angeles Senior High School
Los Angeles, CA

Skills

  • Documentation Review
  • Pharmaceutical Regulations
  • Document Control
  • Regulatory Submissions
  • Audits
  • Excellent Communication
  • Teamwork and Collaboration
  • Document Preparation

Licenses

  • Esthetician License, 11/2021 (Renewed 11/2023), Board of Cosmetology and Barbering

Certification


  • Introduction to Cosmetic and Skincare Science, 06/2024, Olay and offered through Coursera
  • Quality Control and Regulatory in Cosmetic Science, 06/2024, Olay and offered through Coursera
  • Cosmetic Formulation Science, 06/2024, Olay and Offered Through Coursera





Timeline

Regulatory Specialist, II

Velocity Clinical Research
10.2021 - Current

Administrative Assistant

National Research Institute
10.2021 - Current

Regulatory Coordinator

National Research Institute
08.2018 - 10.2021

Esthetician Certification -

Victory Career College

High School Diploma -

Los Angeles Senior High School

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Nataly Madrid