Emily Gonzales
Clinical Research Manager
San Antonio,Texas
Summary
Clinical Research Manager leading day-to-day operations for a retina research department while reporting to regional leadership. Oversees FDA, Good Clinical Practice, and Human Subject Research compliance, mentors staff on study requirements, and coordinates hiring, training, and coaching across active protocols. Partners with regulatory managers and sponsor/CRO teams to keep studies moving cleanly and on schedule.
Overview
2
2
Languages
4
4
Certifications
10
10
years of professional experience
Work History
Clinical Research Manager
Retina Consultants of Texas
07.2021 - Current
- Track 40-50 study workflows weekly across regulatory follow-ups, sponsor communication, and department operations.
- Oversee day-to-day operations of the Spurs Lane Research Department and report directly to the Regional Manager.
- Mentor team members on study processes and requirements while reinforcing FDA, Good Clinical Practice, and Human Subject Research standards.
- Lead hiring, training, and coaching for research staff to support consistent department coverage and performance.
- Coordinate regulatory tasks with the Regulatory Manager and sponsor/CRO partners to keep study documentation aligned.
- Support staff compliance with FDA and Good Clinical Practice guidelines through regular guidance and process review.
Clinical Research Coordinator
Retina Consultants of Texas
02.2022 - 07.2026
- Tracked 80-100 study visits while supporting site operations and sponsor coordination across active protocols.
- Prepared study start-up documents and coordinated sponsor and CRO monitoring visits from initiation through follow-up.
- Reported AE, AESI, and SAE events to the IRB, sponsor, and CRO in line with study timelines.
- Managed IRB and IBC communications, submissions, and follow-up documentation for ongoing research studies.
- Maintained the Investigator Site File and documented sponsor safety report acknowledgments and reviews.
- Trained Clinical Research Assistants on study-specific procedures and reference materials using clear handoff guidance.
Clinical Research Assistant
Retina Consultants of Texas
07.2021 - 02.2022
- Accurately collect and record all necessary data (e.g. demographics, medical history, adverse events, concomitant medications, etc.) during study visit per ALCOA-CCEA guidelines
- Coordinator and schedule patient visits within patient/study-specific windows per protocol guidelines
- Monitor patient flow for Clinical Research Coordinators and assist in patient care and management
- Collect, process, and ship laboratory specimens for analysis per protocol and laboratory manuals
Senior Lead
Old Navy
10.2018 - 07.2021
- Back-up Sales and Service leader to managers when not available
- Engage in customer service questions or concerns
- Receive general instructions directly from store manager on tasks throughout the store
- Help manage groups of 5+ or more while supervisors are occupied with other duties
- Senior Lead
Team Lead
Old Navy
10.2018 - 07.2021
- Trained new associates on company standards across cashier, sales, and floor coverage.
- Assisted customers with finding and ordering clothing items to support sales and improve shopping experience.
- Maintained dependable service in fast-paced environments by adapting quickly to changing store needs.
- Covered cashier, sales, and other floor positions as needed to keep daily operations running smoothly.
- Reinforced company standards through consistent on-the-floor guidance and customer-facing support.
Peer Educator
Institute for Health Disparities Research- Project SHAPE
01.2020 - 05.2020
- Taught evidence-based interventions to reduce substance abuse, HIV/AIDS, and viral hepatitis among at-risk ethnic and racial minorities ages 18-24.
- Created a file of over 100 data entries for project research records using SPSS data entry practices.
- Coordinated outreach events, including HIV and Hepatitis C testing, to support community engagement and participation.
- Built familiarity with demographic reports and descriptive statistics to support research tracking and basic analysis.
Medical Billing Representative
Rachel Dehn, CPA
03.2017 - 08.2018
- Communicate with insurance companies and patients to verify eligibility and other details in regards to doctor visits
- Knowledgeable of HIPAA and other policies related to healthcare systems
- Handled patient copayments and deposit slips for financial department
- Download, scan, and print patient charts for medical record purposes
Education
Master of Science - Healthcare Management
University of Texas at Health Science Center at Houston, School of Public Health
09-2026
Bachelor of Science - Public Health, Epidemiology and Disease Control
University of Texas at San Antonio
01-2020
Skills
- Certified in Good Clinical Practice, Human Subject Research, Information Privacy and Security, Biosafety, and OSHA Bloodborne Pathogens by The Collaborative Institutional Training Initiative (CITI Program), 2021 – present
- Certified in Shipping and Transport of Regulated Biological Materials as required by the International Air Transport Association (IATA) and the US Department of Transportation by CITI Program, 2021 – present
- Certified Clinical Research Professional by SOCRA, 2026 – present
- Electronic Data Capture Certified by iMedidata RAVE, iMedNet, Zelta, Oomnia (Wemedoo), Medrio, Veeva Vault
- Microsoft Office Applications (Word, Excel, PowerPoint, Teams)
- Nextech EMR/Practice Plus, RealTime CTMS, NexGen
- SPSS/data entry software, STATA
Certification
Electronic Data Capture Certified, by iMedidata RAVE, iMedNet, Zelta, Oomnia (Wemedoo), Medrio, Veeva Vault
Timeline
Clinical Research Coordinator
Retina Consultants of Texas
02.2022 - 07.2026
Clinical Research Manager
Retina Consultants of Texas
07.2021 - Current
Clinical Research Assistant
Retina Consultants of Texas
07.2021 - 02.2022
Peer Educator
Institute for Health Disparities Research- Project SHAPE
01.2020 - 05.2020
Senior Lead
Old Navy
10.2018 - 07.2021
Team Lead
Old Navy
10.2018 - 07.2021
Medical Billing Representative
Rachel Dehn, CPA
03.2017 - 08.2018
Bachelor of Science - Public Health, Epidemiology and Disease Control
University of Texas at San Antonio
Master of Science - Healthcare Management
University of Texas at Health Science Center at Houston, School of Public Health