Open to opportunities

Natalie User

@natalieuser3

Message

Clinical research operations professional driving compliant, efficient, on-time clinical programs.

United States

Message

What I'm looking for

I seek a clinical operations role where I can lead site readiness, streamline workflows, and drive compliant, measurable improvements in trial timelines and quality.

I am a clinical research operations professional with 7+ years supporting and driving clinical programs within regulated healthcare environments, focused on improving operational efficiency, managing competing priorities, and ensuring GCP-compliant execution. I have led site onboarding and feasibility, maintained CTMS/TMF oversight, coordinated cross-functional teams, and supported audit and inspection readiness while mentoring junior staff.

My accomplishments include reducing project plan finalization timelines by 40% and increasing on-time deliverables by 30% through standardized workflows and KPI tracking; I have overseen enrollment for hundreds of participants, maintained 100% QA compliance during audits, and strengthened site and vendor partnerships to improve retention and participant experience.

Experience

Work history, roles, and key accomplishments

Clinical Trial Associate

Spark Therapeutics

Oct 2020 - May 2025 (4 years 7 months)

Supported operational execution for multiple clinical programs, improving trial readiness and compliance while reducing project plan finalization timelines by 40% and increasing on-time deliverables by 30%.

Clinical Operations Risk Management KPI Tracking Process Improvement

Clinical Research Coordinator

PMG Research-Winston Salem

May 2017 - Jul 2018 (1 year 2 months)

Managed day-to-day site operations and enrollment for 200+ participants across multiple trials, supported 8+ active studies and improved patient engagement and operational efficiency.

Site management Regulatory Compliance Performance Monitoring

Clinical Research Coordinator Assistant

PMG Research-Winston Salem

May 2016 - May 2017 (1 year)

Supported multi-site study operations with focus on documentation quality and process standardization, maintaining 100% QA compliance during internal audits.

Documentation Management Data Entry QA Process Standardization Tracking Systems

Intern - Recruitment Coordinator

PMG Research-Winston Salem

Oct 2014 - May 2016 (1 year 7 months)

Supported recruitment strategy and data management, contributing to enrollment of 300+ participants and managing CRM and recruitment reporting.

CRM Management Data Management Community Outreach Reporting Provider Engagement Enrollment Strategy

Clinical Research Coordinator

Clinical Research Development & Associates

Aug 2013 - Jul 2014 (11 months)

Managed patient and provider operations, scheduling, and regulatory documentation to support study execution and improved participant retention by 25%.

Scheduling Regulatory Provider Relations