Project Manager and Operations Specialist, B.S. Texas Tech University
Resume:
Amy Irby, B.S.
Outstanding self-starter with excellent ability to multi-task, set priorities, and stay focused on numerous fast- paced projects to meet goals. Passion for providing excellent customer support, creative problem-solving, and producing innovative and quality products. Proven effective communication skills, proficiency in building relationships with key stakeholders, and ease of presenting complicated information in a clear way to individuals and groups. High-performing professional with meticulous attention to detail and demonstrated expertise in project and documentation management, regulatory compliance, quality production, and streamlining operations processes across multiple industries. Key Skills
Project Management Leadership Creative Product Design Adaptability
Proactive Problem-Solving Logistics Regulatory Compliance Teamwork
Strategic Thinking Quality Assurance Continuous Learning Communication Experience
Co-Owner, A Shiny Shop, LLC
San Antonio, TX 02/2026 – present
Product design, development, and production
Bookkeeper, data entry, regulatory compliance
Inventory documentation and online marketing campaigns
Attending shows, conferences, and festivals to interface with customers, promote brand, and sell products Licensed Career Agent, Globe Life: American Income Division San Antonio, TX 8 months 8/2025 – 04/2026
Main point of contact for individuals with life insurance policy needs, inquiries, renewals, and claims.
Called leads and referrals, and scheduled presentations and call backs with potential clients.
Processed applications and renewals for insurance policies and programs and completed data entry. Insurance Producer, Farmers Insurance
Frisco, TX 5 months 3/2025 – 7/2025
Assessed client needs, recommended solutions, and provided ongoing support for insurance coverage.
Called leads and referrals, and managed accounts regarding policy inquiries, renewals, and claims.
Processed applications and renewals for insurance coverage for individuals and businesses and completed data entry. Director of Regulatory and Operations, Iterative Health - Precision Research Grapevine, TX (WFH hybrid role) 4 years 7/2020 – 7/2024
Created and led the Regulatory Documentation division; authored and implemented internal and external SOPs.
Provided support to network of 60+ national sites – document management and storage, compliance with FDA and International Review Board guidelines, Work Orders, Staff Credentials and Certifications, Project Start up and Close out.
Analyzed quality trends of sites and implemented strategic solutions, developed Quality division, Corrective and Preventive Action plans, Audit Readiness program, and Training division.
Designed and implemented staff onboarding process, performance appraisals, and professional development programs.
Drove the development and reporting of metrics and KPIs related to inspection readiness, quality, and performance. ***.****.************@*****.***
https://www.linkedin.com/in/amyirby
Amy Irby
Quality Control, Pinnacle Clinical Research
San Antonio, TX (WFH hybrid role) 1 year 6/2019 - 7/2020
Improved the quality of research data by overseeing adherence to GCP, GDP, FDA CFR, and ICH guidelines.
Managed Quality workflow of study-specific source documents and created department SOPs and workflows.
Conducted quality reviews and staff training to ensure audit-readiness for Sponsor Audits and FDA Inspections.
Led team to efficiently transition sites from paper-based source and regulatory to digital CTMS.
Developed standardized reporting for site metrics, compliance checks, CAPA program, and change management. Data & Quality Manager, Clinical Research Coordinator, PPD-AES-Synexus-Radiant Research San Antonio, TX 2.5 years 11/2016 - 6/2019
Ensured regulatory documentation compliance and completed quality reviews on study source documents.
Performed Lead Coordinator duties for multiple high-enrolling research studies.
Recruited and enrolled subjects, created and managed source documentation, conducted study visits, performed data entry in EDC, managed laboratory procedures and study supplies, packaged and shipped study specimens following IATA guidelines, trained study teams, and adhered to HIPAA, GDP, GCP, and ALCOA+ documentation principles, while negotiating budgets, meeting enrollment goals, working with Investigators and vendors, and providing quality client service.
Education, Certifications & Additional Skills
Bachelor of Science, Merchandising Texas Tech University ACRP-CP Certified ACRP Certified Research Professional GCP Certified CITI & NIDA Good Clinical Practice Programs CPR Certified American Heart Association
Commercial & Personal Property, Casualty, Life, Health, Accident Insurance License Texas, California Research Training & Externship Clinical Research Fastrack Management & Leadership Training LifeLabs
Proficient Office Skills – Microsoft Office, Google Workspace, BOX, Dropbox, Adobe, DocuSign, Zoom, Salesforce, Slack, Asana, Trello, SmartSheets, Learning Management System LMS
Document Management & CTMS - RealTime, CRIO, Clinical Conductor, Complion, Clario, SiteRoom, SIP, Veeva
EDC Data Capture, Study Project Portals - Inform EDC, Medrio, Zelta, Medidata, Suvoda, Cerba, LabCorp, IRT, IVRS / IWRS, eCOA, EHR, EMR
Central and Local IRBs - Advarra, WCG
Training – IATA Transport of Hazardous Materials, HIPAA Guidelines, PHI, Code of Ethics, Anti-Bribery, Lab Skills, Disaster Recovery Plan, Trial Master File TMF, Regulatory Compliance Documentation, Source Creation, CRC Skills Training, Quality Auditing, Inspection Preparedness, Scrum, Agile, Project Management, Clinical Research Basics, EMR EHR Medical Records System Searches, Learning Management System LMS, Research SOPs ***.****.************@*****.***
https://www.linkedin.com/in/amyirby
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