Jill Lewis
Oxford
Summary
An organized and motivated individual, eager to utilize time management and organizational skills across diverse settings. Seeking entry-level opportunities to enhance abilities while contributing to company growth.
Dedicated and adaptable professional with a proactive attitude and the ability to learn quickly. Strong work ethic and effective communication skills. Eager to contribute to a dynamic team and support organizational goals.
Overview
27
27
years of professional experience
6
6
years of post-secondary education
1
1
Certification
Work History
Clinical Data Associate
Rho, Inc.
Durham
08.2024 - 04.2025
- Reviewed protocols and applied protocol-specified guidelines to the review and cleaning of clinical data
- EDC testing and system validation and User Acceptance Testing in Medidata
- Study start-up, maintenance, and finalization tasks and implemented data management plans, data entry and completion guidelines
- Outlined electronic validation checks and communicated these to staff
- Closed, reviewed, generated, and managed queries
- Worked closely with the data management team to ensure quality study execution and client satisfaction
- Managed multiple Excel spreadsheets with updates
Research Associate
Rho, Inc.
Durham
08.2023 - 08.2024
- Worked closely with clinical sites through the collection, review, and approval process for regulatory documents and maintained project website
- Maintained clinical trials management system and other project tracking tools
- Supported audit preparation and supported Trial Master File Audits
- Coordinated and delivered internal/external correspondence such as emails, memos, and letters
- Incorporated updates to manuals and disseminated appropriately to sites
- Coordinated project meetings with the team, sponsor, vendors, and investigators
- Assisted with the preparation of study materials including development of protocols, informed consent forms, study visits, and manuals of operations
- Assessed monthly study status reports for data issues and submitted vendor invoices
- Supported internal standardization efforts for Project Management
- QA/QC of the TMF documents uploaded to the system
Regulatory Documents Specialist
UNC School of Medicine
Chapel Hill
02.2022 - 08.2023
- Maintained and organized regulatory documents, study files, training records and safety information. Performed QA/QC of study files and consent forms
- Tracked and entered regulatory submissions and training information into databases/Excel
- Communicated with study staff, IRB, sponsors, domestic and international study partners for the infectious disease studies
- Assisted other regulatory staff in study submissions and promoting a team environment. Created study submissions for IRB
- Organized visits with sponsors, set up meetings between staff, maintained and distributed meeting minutes
- Participated in guideline development, streamline processes. Trained new study staff on regulatory document procedures
Research Specialist
Open Desk
Wake Forest
05.2021 - 02.2022
- Verified the legitimacy of Workers Comp claims through telephonic and online research
- Used various programs and forms including Microsoft Office and web research
- Formatted documents and followed Workers Comp guidelines
- Met project deadlines with superior quality
- Maintained strong data integrity with keen attention to detail
- Communicated and authenticated information to clients in concise reports
Social Worker
Vance County Department of Social Services
Henderson
09.1998 - 07.2001
- Answered calls with Child Protective Services (CPS) as an Intake Worker
- Case Worker with CPS and interviewed clients, families, or groups to assess situations, limitations and issues and implemented services to address need
- Investigated allegations of child abuse, neglect, and/or dependency
- Assessed clients for abuse and neglect in the home towards children to compile documentation for court reports
- Maintained regular contact with clients by calling and visiting clients' homes
- Worked in the Work First Department and worked with welfare clients to understand needs and provide job and/or schooling services
- Obtained and supplied information to coordinating agencies to provide the best possible guidance to clients
Education
Associate Degree - Clinical Trials Research
Durham Tech Community College
Durham, NC 01.2021 - 05.2023
Bachelor of Arts - Psychology
North Carolina State University
Raleigh, NC 08.1994 - 05.1998
Skills
- Data Management
- Computer Proficiency
- Troubleshooting and Research
- Strategic Thinking
- Problem Solving
- TMF Management
- QA/QC
- Regulatory Compliance
- Customer Engagement and Support
- Query management
- Quality assurance
- Electronic data capture systems
Websites
Certification
Clinical Trials Research Associate-Data Management, Durham Tech Community College, 05/23
Timeline
Clinical Data Associate
Rho, Inc.
08.2024 - 04.2025
Research Associate
Rho, Inc.
08.2023 - 08.2024
Regulatory Documents Specialist
UNC School of Medicine
02.2022 - 08.2023
Research Specialist
Open Desk
05.2021 - 02.2022
Associate Degree - Clinical Trials Research
Durham Tech Community College
01.2021 - 05.2023
Social Worker
Vance County Department of Social Services
09.1998 - 07.2001
Bachelor of Arts - Psychology
North Carolina State University
08.1994 - 05.1998
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