Clinical Research Coordinator

CATHERINA Y. BROWN

Minneapolis, MN ***** 253-***-**** ****************@*****.***

PROFESSIONAL SUMMARY

Results-driven Clinical Research Consultant with 15+ years of experience across all phases of clinical trials—Pre-Clinical, Phase I (First-in-Human), Phase II, Phase III, and Post-Marketing. Demonstrated success in managing pharmaceutical, biotech, and medical device (engineering) trials across diverse environments, including academic institutions, hospitals, outpatient clinics, and community-based research settings. Extensive expertise in decentralized clinical trials

(DCTs) and hybrid models. Recognized for leading large-scale participant recruitment (4,000+ enrolled), ensuring regulatory compliance, and optimizing data quality. Certified in Project Management, with a strong commitment to innovation, collaboration, and continuous improvement.

CORE COMPETENCIES

● Full Lifecycle Clinical Trial Management (Pre-Clinical to Post-Marketing)

● Decentralized & Hybrid Clinical Trials

● Phase I (First-in-Human), II, III, IV Trial Operations

● Biotech, Pharma, and Medical Device (Engineering) Trials

● University, Hospital, Clinic & Community-Based Research

● Regulatory Compliance (GCP, ICH, FDA, IRB Submissions)

● Data Management (Medrio, Redcap, Oracle, EPIC, Florence)

● Participant Recruitment & Retention Strategies

● Project Planning, Budgeting & Contract Negotiation

● Training, SOP Development & Staff Supervision

● Monitoring Preparation, Query Resolution & QA Audits

● Telemedicine Support & Remote Monitoring Technologies PROFESSIONAL EXPERIENCE

Clinical Research Consultant (Contract)

Fairview Frontiers Research – Fairview Health, Saint Paul, MN Jul 2024 – Present

● Designed project workflows for device trials with Apple Inc.

● Led participant recruitment and chart reviews using EPIC EMR.

● Oversaw data entry and quality control across multiple databases (Medrio, Redcap, Oracle).

● Managed study device training, accountability, and logistics.

● Supported regulatory archiving and study documentation. Clinical Research Coordinator (Contract)

Science 37, Culver City, CA – Remote

Aug 2023 – Dec 2023

● Managed decentralized trials via the Metasite platform.

● Conducted telehealth visits, eCRF data entry, and participant compensation.

● Developed project workflows and submitted study metrics. Senior Clinical Research Coordinator (Contract)

Lake Washington Vascular, Bellevue, WA

Jun 2022 – Jan 2023

● Coordinated multiple vascular studies and negotiated trial budgets.

● Trained staff, ensured regulatory compliance, and facilitated monitoring visits. Traveling Clinical Research Coordinator (Contract) Care Access Research, Boston, MA

Dec 2021 – Aug 2022

● Managed clinical operations at decentralized trial sites.

● Conducted community outreach and laboratory specimen handling per IATA standards. Senior Clinical Research Coordinator (Contract)

Eastside Research Associates / Evergreen Health, Redmond, WA Aug 2020 – Jan 2021

● Implemented COVID-19 clinical trials; supported remote audits and EDC systems.

● Served as ERA Leadership advisor and contributed to business development. Project Manager (Consultant)

Styles of Steppin’, Federal Way, WA

Jan 2014 – Aug 2020

● Led fundraising projects for national health causes.

● Managed a 20+ person team, created SOPs, and oversaw contracts and budgets. Health Care Coordinator (Contract)

Private Client, Tacoma, WA

Jan 2014 – Aug 2019

● Provided clinical oversight in a home-care setting including rehab support and medical coordination.

Lead Clinical Research Coordinator

Department of Veterans Affairs, Seattle, WA

Jul 2010 – Jan 2014

● Managed the MVP Trial; enrolled 4,000+ participants and led contract negotiations.

● Conducted audits and ensured 100% query resolution. Clinical Project Manager (Contract)

Spacelabs Healthcare / Delmar Reynolds, Issaquah, WA Aug 2008 – Nov 2009

● Oversaw clinical strategy and logistics for nationwide equipment trials. Sr. Clinical Research Coordinator / Project Manager Trainee (Contract) Northwest Kinetics / Charles River, Tacoma, WA

Sep 2007 – May 2008

● Supported early-phase biotech studies and FDA audits. Clinical Study Manager (Contract)

Medtronic ERS / Physio-Control, Redmond, WA

Feb 2006 – Jan 2007

● Managed a pilot AED study in Norway; developed multilingual training materials and monitoring plans.

EDUCATION & CERTIFICATION

Certificate in Project Management – University of Washington, Tacoma, WA BFA-Bachelor Fine Arts – Cornish College of the Arts, Seattle, WA History/Black Studies – University of Washington, Seattle, WA TECHNICAL SKILLS

EPIC Medrio Redcap Oracle Florence Veeva Vault Intellitrial CTMS Metasite Microsoft Office Suite Virtual Incentives IATA Standards

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