Jeffrey Wilson
Lancaster,TX
Summary
Certified Clinical Research Professional (CCRP) with over 15 years of experience in clinical research quality assurance, regulatory compliance, and clinical trial operations. Skilled in SOP development, CAPA implementation, risk-based monitoring, audit readiness, and regulatory documentation. Proficient with CTMS and EDC systems, including Rave, Veeva Vault, and REDCap. Committed to ensuring GCP/FDA compliance, enhancing data integrity, and driving continuous quality improvement across multidisciplinary teams.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Regulatory Research Specialist
Methodist Health System
Dallas, TX (Hybrid)
11.2023 - Current
- Authored and revised Standard Operating Procedures (SOPs) to ensure alignment with FDA, GCP, and institutional standards, directly supporting inspection readiness, and consistent quality practices across research projects.
- Monitored project progress, and proactively identified compliance risks, implementing corrective measures that maintained operational integrity and minimized protocol deviations.
- Prepared and organized IRB review materials, streamlining regulatory documentation workflows, and enhancing the efficiency and accuracy of protocol review processes.
- Provided technical consultation and regulatory guidance to investigators and research staff, fostering continuous process improvement, and promoting a strong culture of compliance and quality assurance.
Regulatory Monitoring Analyst
University Texas Southwestern Medical Center
Dallas, TX (Remote)
05.2019 - 09.2023
- Conducted internal quality assurance audits to ensure adherence to protocols, SOPs, federal regulations and guidelines.
- Developed and implemented CAPAs post-audit, ensuring continuous improvement in research compliance and human subject protection.
- Educated and trained investigators and research staff on GCP standards, evolving regulatory expectations, and best practices.
- Increased regulatory compliance rates by 15% by implementing new training programs.
Senior Regulatory Analyst (Team Lead)
University Texas Southwestern Medical Center
Dallas, TX (Remote)
04.2017 - 05.2019
- Led quality control activities within the Human Research Protection Program (HRPP) by conducting detailed protocol pre-reviews and regulatory assessments, ensuring consistency with IRB policies, FDA regulations, and institutional SOPs prior to submission.
- Supported external audit readiness by providing inspection consultation, identifying key personnel for audit engagement, and ensuring the availability and accuracy of study documentation, contributing to successful audit outcomes.
- Developed and evaluated internal controls and compliance procedures to improve research operations, enforce institutional standards, and support the effectiveness of corrective and preventive action (CAPA) plans.
- Provided regulatory training and consultation to investigators and research staff, identifying compliance risks, enhancing protocol feasibility, and promoting continuous improvement in alignment with evolving federal and institutional quality standards.
Clinical Research Coordinator II
University Texas Southwestern Medical Center
Dallas, TX (Remote)
03.2016 - 04.2017
- Performed routine reviews of clinical study documentation to ensure compliance with protocol, institutional policies, and federal regulations (FDA, ICH-GCP), proactively identifying discrepancies, and coordinating with study teams to implement corrective actions.
- Prepared protocols and amendments for IRB submission, and supported regulatory reporting, contributing to audit readiness and reducing delays due to documentation deficiencies or compliance issues.
- Monitored patient safety and data integrity by reviewing clinical records, reporting adverse events per protocol, and coordinating follow-up with investigators, contributing to risk mitigation and protocol adherence.
- Led in-service training for study team members, sharing updates on protocol compliance and regulatory requirements, which promoted continuous process improvement, and reinforced quality standards across research operations.
Disease Surveillance Specialist
Austin/Travis County Health Human Service
Austin, TX
04.2013 - 11.2015
- Managed and coordinated disease surveillance, ensured effective monitoring and outbreak response.
- Acted as the primary liaison with regional and Texas Department of State Health Services offices for data system issues.
- Coordinated the monitoring of sexually transmitted infections and seasonal diseases, including influenza and West Nile Virus, during peak periods.
Clinical Research Coordinator
Sirius Clinical Research
Austin, TX
11.2011 - 02.2013
- Ensured strict adherence to study protocols and regulatory guidelines (FDA, GCP, ICH) by conducting thorough participant eligibility assessments, documentation reviews, and data verification throughout the trial lifecycle.
- Maintained comprehensive and accurate participant records, supporting data integrity, and facilitating quality control processes and audit readiness for allergy and asthma clinical trials.
- Monitored visit schedules and protocol-specific procedures, identifying and resolving deviations in collaboration with investigators to maintain compliance and safeguard participant safety.
- Handled study documentation and data collection with meticulous attention to detail, contributing to high-quality deliverables, and enabling successful sponsor monitoring visits and inspections.
Research Project Manager (Contract)
US Army/Baylor Doctoral Physical Therapy
Fort Sam Houston, TX
09.2010 - 10.2011
- Oversaw the execution of multiple research projects, ensuring strict compliance with study protocols, regulatory timelines, and IRB requirements, proactively identifying risks, and implementing corrective actions to maintain study integrity.
- Implemented quality control checkpoints throughout the project lifecycle, identifying potential compliance issues early, and advising on preventive measures to support successful research outcomes.
- Collaborated cross-functionally with research and administrative teams, contributing to the development of standard practices, and reinforcing regulatory compliance and quality assurance throughout the program.
Clinical Research Associate I (CRA)
DJO Surgical
Austin, TX (Remote)
09.2007 - 10.2009
- Conducted comprehensive monitoring visits across multiple clinical sites, ensuring adherence to study protocols, IRB requirements, and FDA regulations for Class II and III orthopedic device trials.
- Performed detailed source data verification and regulatory document reviews, identifying discrepancies, and coordinating with site staff to implement timely corrective actions in line with QA standards.
- Investigated reportable events and protocol deviations, leading resolution efforts, and documentation updates in compliance with IRB and FDA expectations to support patient safety and regulatory integrity.
- Contributed to the preparation and submission of Investigational Device Exemptions (IDEs) and Premarket Approval (PMA) applications, supporting successful sponsor inspections, and enhancing organizational inspection readiness.
Education
Bachelor of Science - Exercise Sport Science
Texas State University
San Marcos, TexasSkills
- Clinical Research Quality Assurance
- Clinical Trial Operations and Coordination
- Regulatory Compliance and Oversight
- Audit Preparation and Inspection Readiness
- Risk-Based Monitoring and Quality Management Systems
- SOP Development and Implementation
- Data Integrity and Documentation Review
- Cross-Functional Collaboration and Training
- MS Office (Word, Excel, Outlook, PowerPoint)
- Regulatory and Clinical Research Management Systems
Certification
- Certified Clinical Research Professional (CCRP), Society of Clinical Research Associates (SoCRA), 06/01/06
- Research HIPAA, Collaborative Institutional Training Initiative (CITI Program), 01/01/16
- Conflict of Interest Training (COI), Collaborative Institutional Training Initiative (CITI Program), 01/01/17
- Human Subjects Research, Collaborative Institutional Training Initiative (CITI Program), 01/01/23
- Good Clinical Practice (GCP), Collaborative Institutional Training Initiative (CITI Program), 01/01/23
- Shipping and Transport of Regulated Biological Materials, Collaborative Institutional Training Initiative (CITI Program), 01/01/24
Timeline
Regulatory Research Specialist
Methodist Health System
11.2023 - Current
Regulatory Monitoring Analyst
University Texas Southwestern Medical Center
05.2019 - 09.2023
Senior Regulatory Analyst (Team Lead)
University Texas Southwestern Medical Center
04.2017 - 05.2019
Clinical Research Coordinator II
University Texas Southwestern Medical Center
03.2016 - 04.2017
Disease Surveillance Specialist
Austin/Travis County Health Human Service
04.2013 - 11.2015
Clinical Research Coordinator
Sirius Clinical Research
11.2011 - 02.2013
Research Project Manager (Contract)
US Army/Baylor Doctoral Physical Therapy
09.2010 - 10.2011
Clinical Research Associate I (CRA)
DJO Surgical
09.2007 - 10.2009
Bachelor of Science - Exercise Sport Science
Texas State University
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