Haley Leventer
Seattle,WA
Summary
Accomplished Country Start Up Specialist with 9+ years of experience in clinical research, specializing in regulatory compliance, site management, and data integrity. Adept at streamlining processes to achieve regulatory milestones, ensuring quality and compliance, and leading cross-functional coordination.
Overview
10
10
years of professional experience
Work History
Startup Specialist
Thermo Fisher Scientific
11.2022 - 07.2025
- Coordinate the collection and review of required regulatory documents from sites to ensure accuracy, compliance, and readiness for site activation.
- Serve as the primary country-level contact for regulatory and ethical submission activities.
- Manage country-specific documents, including informed consents.
Senior Remote Site Monitor (RSM-L)
Thermo Fisher Scientific
07.2020 - 11.2022
- Managed two Phase II, double-blind, placebo-controlled, randomized clinical trials in Cardiology (Stroke) and Oncology (Melanoma).
- Provided ongoing site support and training, ensuring compliance with GCP guidelines.
- Reduced outstanding data queries by 20% through proactive monitoring and communication.
Regulatory Data Entry Coordinator
Northwest Clinical Research Center
09.2015 - 03.2020
- Coordinated daily clinical trial activities in Nervous System studies.
- Supported the PI, sponsors, and study teams to maintain data integrity and regulatory compliance.
- Maintained trial master files and facilitated CRA visits, site initiation, and close-out visits.
Education
BA - Psychology
University of Washington
Seattle, WA06.2015
Skills
- Clinical Trial Management Systems (CTMS, Activate, eTMF, Immedidata)
- Regulatory Submission Coordination (IRB, MoH EC)
- Data Integrity and Query Resolution
- Site Activation and Monitoring
- Strong Communication
- Computer Literacy
- Problem Solving
LANGUAGES
English: Fluent
Timeline
Startup Specialist
Thermo Fisher Scientific
11.2022 - 07.2025
Senior Remote Site Monitor (RSM-L)
Thermo Fisher Scientific
07.2020 - 11.2022
Regulatory Data Entry Coordinator
Northwest Clinical Research Center
09.2015 - 03.2020
BA - Psychology
University of Washington
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