Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

Sonia Guerrero

Houston

Summary

Dynamic Regulatory Specialist at DM Clinical Research with expertise in regulatory submissions and compliance. Proven track record in streamlining processes, enhancing efficiency, and improving approval timelines. Strong organizational skills and critical thinking drive successful project outcomes, ensuring adherence to FDA regulations and optimizing internal audits for continuous improvement.

Overview

10
10
years of professional experience

Work History

Regulatory Specialist

DM Clinical Research
06.2024 - 05.2025
  • Streamlined regulatory submission processes for increased efficiency and reduced approval timeframes.
  • Optimized internal audit processes, identifying areas for improvement in regulatory adherence.
  • Provided expert guidance on regulatory requirements, supporting the development of compliant products and services.
  • Ensured timely renewal of licenses and registrations through meticulous tracking systems, preventing lapses that could impact business operations.
  • Collaborated with cross-functional teams to ensure successful product launches in line with relevant regulations.
  • Maintained and archived regulatory documents.
  • Prioritized project-related tasks to efficiently complete essential tasks.
  • Prepared and submitted regulatory file applications and supporting documentation.
  • Developed or tracked quality metrics.

Clinical Training Specialist

DM Clinical Research
04.2023 - 06.2024
  • Evaluated training effectiveness using feedback surveys and assessments, making continuous improvements as needed.
  • Assessed additional needs based on training progress and collaborated with management to meet requirements.
  • Collected data on program effectiveness to develop modifications and improvements to curricula.
  • Promoted a culture of continuous improvement by conducting regular follow-ups with trainees post-training sessions.
  • Assisted in analyzing and assessing training and development needs for organizations, departments and individuals.
  • Supported the professional development of fellow trainers by providing constructive feedback and sharing insights on effective teaching methodologies.
  • Streamlined onboarding process for new hires, resulting in reduced time to productivity.
  • Established a mentorship program to facilitate knowledge sharing between experienced employees and new hires, enhancing overall team performance.
  • Facilitated virtual, in-person and blended learning sessions.
  • Developed and implemented successful onboarding program.

Clinical Research Coordinator

DM Clinical Research
08.2020 - 04.2023
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Gathered, processed, and shipped lab specimens.
  • Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
  • Followed informed consent processes and maintained records.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
  • Maintained accurate and up-to-date case report forms and source documents for traceability.
  • Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
  • Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
  • Streamlined data collection processes for increased efficiency and accuracy in study results.

Administrative Assistant

DM Clinical Research
03.2017 - 08.2020
  • Answered multi-line phone system, routing calls, delivering messages to staff and greeting visitors.
  • Maintained confidentiality of sensitive information by adhering to strict privacy policies and implementing secure filing systems.
  • Delivered excellent customer service through prompt responses to client inquiries, addressing concerns effectively, and building strong relationships.
  • Ensured accurate record-keeping with diligent data entry and database management for vital company information.
  • Promoted a positive work environment through effective communication skills and fostering professional relationships among colleagues.
  • Coordinated office supply inventory management, proactively ordering necessary items before depletion to avoid workflow disruptions.
  • Organized office events such as holiday parties or team-building activities, promoting a positive company culture and boosting employee morale.
  • Maintained inventory of clinical studies supplies and placed orders.
  • Managed paper and electronic filing systems by routing various documents, taking messages and managing incoming and outgoing mail.
  • Assisted coworkers and staff members with special tasks on daily basis.
  • Created and maintained detailed administrative processes and procedures to drive efficiency and accuracy.

Front Desk Receptionist

Texas Gastro
03.2015 - 03.2017
  • Greeted guests at front desk and engaged in pleasant conversations while managing check-in process.
  • Maintained organized and clean front office area to create professional and welcoming environment for visitors and employees.
  • Scheduled, coordinated and confirmed appointments and meetings.
  • Managed high-volume phone calls, directing inquiries to appropriate personnel for prompt resolution.
  • Collected clinic visit fees, and payments.
  • Insurance Verification for Colonoscopy and EGD procedures
  • Handled sensitive customer information with confidentiality, adhering to company privacy guidelines.
  • Developed strong working relationships with team members, fostering a positive work environment.
  • Completed all tasks in compliance with company policies and procedures.

Education

High School Diploma -

Rio Grande City High School
Rio Grande City, TX
05-2001

Skills

  • Labeling compliance
  • Documentation review
  • Policy analysis
  • Ethics management
  • Privacy regulations
  • Regulatory reporting
  • Regulatory submissions
  • Regulatory policies
  • Audits
  • Inspections
  • Document control
  • FDA regulations
  • Teamwork and collaboration
  • Time management
  • Attention to detail
  • Leadership skills
  • Problem-solving abilities
  • Multitasking ability
  • Reliability
  • Critical thinking
  • Task prioritization
  • Regulatory research

Languages

Spanish
Native or Bilingual

Timeline

Regulatory Specialist

DM Clinical Research
06.2024 - 05.2025

Clinical Training Specialist

DM Clinical Research
04.2023 - 06.2024

Clinical Research Coordinator

DM Clinical Research
08.2020 - 04.2023

Administrative Assistant

DM Clinical Research
03.2017 - 08.2020

Front Desk Receptionist

Texas Gastro
03.2015 - 03.2017

High School Diploma -

Rio Grande City High School

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Sonia Guerrero