Stephanie Walker
Davenport,FL
Summary
Experienced Quality Assurance Auditor with over 14 years of experience in Auditing, Compliance, Regulatory Affairs, and Data Management. Possesses a proven track record of effectively managing day-to-day compliance operations, site internal audits, and FDA site preparations. Attentive to details, analytical thinker, and good communicator. Holding the esteemed Certified Clinical Research Professional (CCRP) credential from the Society of Clinical Research Associates (SOCRA).
Overview
14
14
years of professional experience
Work History
Quality Assurance Auditor I & II
Accelerated Enrollment Solutions - ThermoFisher
01.2020 - Current
- Conduct over 60 comprehensive site quality assurance audits for clinical research trials to ensure compliance with regulatory standards, Good Clinical Practice (GCP) guidelines, and Standard Operating Procedures (SOPs)
- Maintain audit plans and schedules, ensuring timely and client completion of audit activities
- Successfully provided comprehensive site support and facilitated over five (5) FDA inspections, resulting in favorable outcomes and compliance with regulatory requirements
- Prepare detailed audit reports, documenting findings and recommendations for management and stakeholders
- Analyze and evaluate study documents, data, and processes to identify non-compliance issues and deviations from protocol requirements
- Collaborate with cross-functional teams, including site staff, investigators, and study coordinators, to address audit findings and implement corrective and preventive actions (CAPAs)
- Track and monitor Corrective and Preventive Action Plans (CAPAs) to ensure their effectiveness and timely closure.
Quality Compliance Associate
Bioclinica Research, Formerly Compass Research
05.2017 - 01.2020
- Successfully managed over 50 Sponsor/CRO audits and seven (7) FDA Regulatory Inspections, demonstrating commitment to maintaining compliance and adherence to regulatory standards
- Coordinated efficiently and comprehensive audit follow-up activities, proactively communicating observations to management and study team for timely resolution
- Played key role in conducting site audit preparation activities, collaborating closely with the study team to ensure thorough readiness and seamless audit processes
- Demonstrated strong attention to detail by meticulously reviewing and tracking protocol deviations, providing insightful metrics to management for informed decision-making
- Actively contributed to process improvement initiatives by assisting management in creating and implementing new processes and procedures, enhancing operational efficiency
- Monitored and tracked Corrective and Preventive Action Plans (CAPA), ensuring implementation and compliance with quality standards.
Lead Regulatory Associate
Compass Research
05.2015 - 05.2017
- Successfully prepared and coordinated over 65 IRB submissions across various Central Institutional Review Boards, ensuring timely approvals and compliance with regulatory guidelines
- Maintained effective communication with the Principal Investigator and relevant study start-up team members, providing regular updates on study progress and regulatory matters
- Collaborated closely with Sponsors, CROs, and CRAs to facilitate seamless regulatory compliance throughout the duration of clinical trials
- Provided crucial FDA support and inspection readiness training to site staff, bolstering preparedness for potential regulatory inspections
- Demonstrated strong organizational skills by efficiently managing new study assignments
- Conducted thorough internal audits to assess and ensure adherence to study protocols and regulatory requirements
- Compiled and presented comprehensive monthly regulatory team metrics to management, providing valuable insights into team performance and areas for improvement.
Oncology Regulatory Project Coordinator
MD Anderson Cancer Center, Orlando Health
09.2012 - 05.2015
- Efficiently prepared and submitted more than 100 IRB Submissions for the Institutional Review Board process, ensuring timely approval for clinical research studies
- Coordinated and prepared individual research projects, displaying excellent time management skills to meet all project deadlines successfully
- Demonstrated exceptional organizational abilities by maintaining and organizing all regulatory documentation for over 100 clinical research studies, ensuring easy accessibility and compliance with industry standards
- Diligently monitored and reported protocol deviations and violations, facilitating comprehensive Institutional Review
- Board review and ensuring study integrity
- Fostered open and effective communication with Sponsors, CROs, and CRAs, ensuring seamless regulatory compliance throughout the duration of clinical trials
- Proactively facilitated weekly meetings within the study team, taking charge of creating comprehensive agendas and meticulous meeting minutes for "POD" meetings to foster a collaborative and organized work environment.
Oncology Data Manager
MD Anderson Cancer Center, Orlando Health
06.2009 - 09.2012
- Carefully reviewed and extracted clinical trial data from more than 50 clinical research studies, ensuring accurate and timely data retrieval
- Assisted in preparing for internal data quality and control audits, contributing to maintaining high data integrity and compliance with regulatory requirements
- Conducted comprehensive compliance reviews, comparing data entered into the Electronic Data Capture (EDC) system with source data to ensure data accuracy and consistency
- Acted as a reliable liaison for effective communication with numerous Sponsors, CRAs, CROs, and essential personnel involved in each clinical trial, fostering strong collaborative relationships and facilitating smooth study operations.
Education
Bachelor of Science - Supervision and Management: Healthcare Administration
Polk State College
Winter Haven, FL2024
Associate of Science - Legal Studies
Draughons Junior College of Business
Nashville, TNSkills
Quality Assurance
Regulatory Compliance
Good Clinical Practice (GCP)
Corrective and Preventive Action (CAPA)
Internal Auditing
Quality Control
Quality Management System (QMS)
Document Management
Critical Thinking
Adaptability
Timeline
Quality Assurance Auditor I & II
Accelerated Enrollment Solutions - ThermoFisher
01.2020 - Current
Quality Compliance Associate
Bioclinica Research, Formerly Compass Research
05.2017 - 01.2020
Lead Regulatory Associate
Compass Research
05.2015 - 05.2017
Oncology Regulatory Project Coordinator
MD Anderson Cancer Center, Orlando Health
09.2012 - 05.2015
Oncology Data Manager
MD Anderson Cancer Center, Orlando Health
06.2009 - 09.2012
Bachelor of Science - Supervision and Management: Healthcare Administration
Polk State College
Associate of Science - Legal Studies
Draughons Junior College of Business
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