SHANNON LEWTON
Camas,Washington
Summary
Clinical project professional with extensive experience in clinical trial management and stakeholder communication. Proven track record in ensuring GCP compliance and enhancing workflow efficiency. Expertise in risk management and process improvement, leading to successful project outcomes through effective collaboration and accurate data tracking.
Overview
10
10
years of professional experience
Work History
Assistant Clinical Project Manager I
Clario
03.2024 - 10.2025
- Supported project managers with study planning, timelines, and sponsor communications to ensure smooth execution.
- Assisted with site activation, monitoring tasks, and project close-out documentation for multiple clinical studies.
- Managed financial tracking, scope updates, and forecasting reports aligned with project deliverables and budgets.
- Monitored project risks, tracked metrics, and implemented solutions ensuring adherence to sponsor expectations.
- Ensured full compliance with GCP, ICH, and FDA standards across all assigned studies.
Image Research Associate II
Clario
04.2022 - 03.2024
- Coordinated site training, imaging data reviews, and technical support for radiograph and DXA studies.
- Managed imaging quality control, study data validation, and discrepancy resolution within regulated environments.
- Assisted project teams with reporting, tracking timelines, and supporting sponsor audit readiness activities.
- Provided process improvement feedback and mentoring to enhance workflow efficiency and team collaboration.
- Ensured strict adherence to study protocols, SOPs, and regulatory standards across clinical operations.
Image Research Associate I
Clario
10.2020 - 04.2022
- Supported study initiation, document preparation, and data collection activities across multiple research programs.
- Monitored data integrity, performed imaging quality control, and maintained compliance with SOPs and GCP.
- Coordinated site communications, ensuring accurate submissions and timely issue resolution across global studies.
- Collaborated with project managers to track progress, generate reports, and maintain protocol compliance.
- Contributed to staff training, workflow improvements, and internal documentation for continuous quality enhancement.
Office Manager
Monti Electric Inc.
11.2015 - 03.2020
- Oversaw administrative operations, payroll, invoicing, and project documentation for 40+ active projects.
- Streamlined office processes, improving reporting accuracy, communication, and document control across departments.
- Maintained financial records, processed AP/AR transactions, and ensured compliance with accounting procedures.
- Coordinated permits, project binders, and client correspondence to support timely project closeouts.
- Enhanced workflow efficiency by standardizing job setup procedures within company accounting software.
Education
Bachelor of Business Administration -
Colorado Technical University Online
Colorado Springs, CO12.2024
Associate of Health Administration -
Colorado Technical University Online
Colorado Springs, CO09.2016
Skills
- Clinical trial management
- Project coordination
- Data tracking
- GCP and ICH compliance
- Site start-up
- Stakeholder communication
- Regulatory documentation
- Process improvement
- Audit support
- Risk management
- Cross-functional collaboration
- Sponsor relations
Communication And Leadership
Strong communicator and liaison among cross-functional teams, sponsors, and clinical sites. Mentored team members, led workflow training, and improved documentation systems ensuring operational excellence and audit readiness.
Timeline
Assistant Clinical Project Manager I
Clario
03.2024 - 10.2025
Image Research Associate II
Clario
04.2022 - 03.2024
Image Research Associate I
Clario
10.2020 - 04.2022
Office Manager
Monti Electric Inc.
11.2015 - 03.2020
Bachelor of Business Administration -
Colorado Technical University Online
Associate of Health Administration -
Colorado Technical University Online