Summary
Overview
Work History
Education
Skills
Timeline
Generic

Erin Bonwit

Portland,OR

Summary

Senior Clinical Research Leader with 10+ years of experience in the medical device industry and a strong clinical foundation in emergency medicine and patient care. Specialized in neurovascular clinical trials, clinical operations, and team leadership. Proven ability to lead cross-functional teams, manage complex global studies, and ensure compliance with GCP, ICH, FDA, and ISO 14155 regulations. Known for driving operational excellence, audit readiness, and delivering trials on time and within budget.

Overview

16
16
years of professional experience

Work History

Associate Director, Safety & Data Integrity

Conformal
05.2025 - Current
  • Lead clinical safety and data integrity strategy across clinical programs
  • Provide cross-functional leadership across Clinical Operations, Data Management, and Regulatory
  • Drive audit readiness and regulatory compliance initiatives
  • Implement process improvements to enhance data quality and execution

Clinical Trial Manager (Neurovascular)

Medtronic
01.2023 - 01.2025
  • Led global neurovascular trials from start-up through close-out
  • Managed CRA deliverables and monitoring oversight ensuring GCP compliance
  • Resolved site issues and protocol deviations to maintain timelines
  • Partnered cross-functionally to deliver studies on time and within budget

Manager, Medical Affairs

Medtronic
01.2022 - 01.2025
  • Led clinical and scientific strategy support for clinical programs
  • Collaborated on study design, protocol development, and execution

Principal Clinical Safety Specialist

Medtronic
01.2018 - 01.2022
  • Oversaw global safety operations and regulatory compliance
  • Led risk assessment, signal detection, and mitigation strategies

Clinical Research Specialist

Medtronic
01.2016 - 01.2018
  • Conducted remote monitoring and site oversight
  • Conducted risk-based monitoring and site performance tracking

Stroke Program Clinical Lead

Florida Hospital
01.2014 - 01.2015
  • Led development of stroke program improving treatment times and patient outcomes
  • Collaborated with physicians to implement evidence-based stroke protocols

Clinical Research Nurse

Florida Hospital
01.2013 - 01.2014
  • Managed patient enrollment, consent, and protocol execution in clinical trials
  • Ensured GCP compliance and supported audits and monitoring visits

Nurse Manager (Emergency Department)

Florida Hospital
01.2011 - 01.2013
  • Supervised operations of a high-acuity emergency department
  • Led staff, scheduling, and quality improvement initiatives

Emergency Room Nurse

Florida Hospital
01.2010 - 01.2011
  • Delivered critical care in a high-volume emergency department setting
  • Performed rapid triage, patient stabilization, and emergency interventions
  • Collaborated with multidisciplinary teams in life-threatening situations
  • Built strong clinical judgment, decision-making, and patient safety expertise

Education

MBA -

Florida International University

Bachelor of Science in Nursing -

University of Central Florida

Skills

  • Clinical Trial Leadership
  • CRA Team Management
  • Neurovascular Studies
  • GCP/ICH/FDA Compliance
  • Audit Readiness
  • Cross-Functional Leadership
  • Risk Management & CAPA
  • Site Monitoring Oversight
  • Study Start-up to Close-out
  • Vendor Management
  • Clinical Systems (Veeva, iMedNet, EDC)
  • Acute Patient Care & Emergency Medicine

Timeline

Associate Director, Safety & Data Integrity

Conformal
05.2025 - Current

Clinical Trial Manager (Neurovascular)

Medtronic
01.2023 - 01.2025

Manager, Medical Affairs

Medtronic
01.2022 - 01.2025

Principal Clinical Safety Specialist

Medtronic
01.2018 - 01.2022

Clinical Research Specialist

Medtronic
01.2016 - 01.2018

Stroke Program Clinical Lead

Florida Hospital
01.2014 - 01.2015

Clinical Research Nurse

Florida Hospital
01.2013 - 01.2014

Nurse Manager (Emergency Department)

Florida Hospital
01.2011 - 01.2013

Emergency Room Nurse

Florida Hospital
01.2010 - 01.2011

MBA -

Florida International University

Bachelor of Science in Nursing -

University of Central Florida
Erin Bonwit