Detail-oriented clinical research professional with extensive experience supporting sponsor, site, and CRO teams. Strong background in document management, timeline tracking, and regulatory correspondence. Known for clear communication, accuracy, and reliable support during study startup, review meetings, and audit preparation.
Overview
19
19
years of professional experience
Work History
Principal Clinical Trial Coordinator
Thermo Fisher Scientific
Wilmington, North Carolina
10.2007 - Current
Coordinated clinical trial start-up activities across Thermo Fisher Scientific sponsor and site teams.
Managed study documents, regulatory files, and trial master file updates.
Supported IRB submissions, amendments, and site activation paperwork.
Scheduled meetings, monitored timelines, and maintained study communication logs.
Prepared status reports and coordinated materials for clinical operations reviews.
Responded promptly to queries from regulatory authorities or sponsors regarding protocol amendments.
Prepared documents for Institutional Review Board submissions.
Reviewed source documents for accuracy prior to database entry or query resolution.
Ensured completion of all required regulatory documents such as informed consent forms, adverse event logs.
Provided support in preparing presentations on clinical trial status updates at meetings or conferences.
Organized and tracked essential documents related to clinical trials according to ICH GCP guidelines.
Facilitated communication between sponsors and CROs, sites, and internal departments throughout the course of a trial.
Coordinated with internal teams to ensure accuracy of data collection and reporting.
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