Open to opportunities

Michelle User

@michelleuser6

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Certified Clinical Research Coordinator with 15+ years' trial oversight.

United States

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What I'm looking for

I am seeking a senior clinical research role focused on regulatory compliance, data quality, and inspection readiness within collaborative teams that value strong processes and professional growth.

I am a Certified Clinical Research Coordinator (CCRC) with more than 15 years of experience supporting academic, private practice, and CRO clinical research across Phase I–IV trials.

I have managed data and quality oversight for 75+ trials in rheumatology, autoimmune, dermatology, infectious disease, vaccine, and rare-disease portfolios, and coordinated recruitment, study visits, and regulatory activities for complex protocols.

In recent roles I oversaw regulatory submissions, QC review, inspection readiness for 20+ trials, built eSource templates, and maintained data accuracy across CRIO, RealTime CTMS, and EMRs while supporting audits and training staff.

I am proficient in eTMF/CTMS management, EMR & EDC systems, GCP/ICH regulatory standards, and client/sponsor communication, and I bring a proven track record of ensuring inspection readiness and regulatory compliance.

Experience

Work history, roles, and key accomplishments

Quality & Compliance Coordinator

TrueBlue Clinical Research

Jan 2022 - Jan 2025 (3 years)

Oversaw regulatory submissions, QC review, and inspection readiness for 20+ trials; built eSource templates and maintained data accuracy across CRIO, RealTime CTMS, and EMRs while supporting audits and staff training.

Regulatory Compliance CRI O EMR Quality Control Staff Training

Clinical Research Coordinator

Bay Area Arthritis & Osteoporosis Research

Jan 2020 - Dec 2020 (11 months)

Coordinated patient recruitment, study visits, and data entry for rheumatology trials; managed regulatory binders, adverse event documentation, and patient follow-up to ensure protocol adherence.

Regulatory Binder Patient Recruitment Adverse Events Data Entry GCP)EMR GCP

Clinical Research Associate

University of South Florida

Jan 2010 - Dec 2020 (10 years 11 months)

Supported rheumatology research including RA and autoimmune studies, oversaw IRB submissions and source documentation, and coordinated 150+ patient visits ensuring FDA and institutional compliance.