Ashley Bowman
Chicago
Summary
Dynamic regulatory and clinical research management professional with over 10 years of experience supporting clinical trials in academic medical centers and industry environments. Recognized for leadership in regulatory compliance, team development, IRB submissions, and fostering cross-functional collaboration. Expertise in streamlining operations and enhancing regulatory processes ensures adherence to federal, institutional, and sponsor requirements. Committed to leveraging regulatory acumen and leadership skills in a management role that drives operational efficiency and elevates staff performance.
Overview
11
11
years of professional experience
Work History
Senior Regulatory Coordinator-Regulatory Manager
Northwestern University
Chicago, IL
12.2022 - Current
- Leads regulatory operations and manage a team of five regulatory coordinators supporting clinical studies across Northwestern University
- Ensures compliance with institutional, federal, and sponsor regulatory standards
- Oversees preparation, review, and submission of regulatory documentation including new studies, amendments, continuing reviews, and reportable events
- Supports protocol development and troubleshoot study-specific regulatory challenges
- Facilitates communication between study teams, sponsors, and regulatory bodies to maintain trial integrity and continuity
Clinical Operations Specialist
Hollister Incorporated
Libertyville, IL
01.2021 - 12.2022
- Implemented and maintained quality system effectiveness across clinical programs
- Submitted new clinical studies and managed amendments and continuing reviews with IRB
- Coordinated logistics for over 200 clinical supply shipments, ensuring participant satisfaction and protocol adherence
- Managed documentation for 15 clinical studies, streamlining record routing and exception reporting processes
- Supported data monitoring and reporting process improvements, reducing turnaround times
Senior Regulatory Coordinator
Aerotek (Northwestern University Assignment)
Chicago, IL
01.2020 - 10.2020
- Served as primary regulatory contact for studies within the Bluhm Cardiovascular Clinical Trials Unit
- Prepared and submitted IRB applications, amendments, informed consent documents, and reportable new information
- Collaborated with IRB and industry sponsors to ensure accuracy and regulatory compliance
- Tracked approvals and expiration dates to prevent lapses in study authorization
Clinical Regulatory Research Coordinator
Rush University Medical Center
Chicago, IL
04.2018 - 01.2020
- Managed regulatory oversight for 70+ research protocols
- Completed electronic submissions through the Rush Research Portal including coverage analysis, IRB applications, and contracts
- Maintained regulatory binders and ensured version control
- Communicated with IRB and sponsors on behalf of study teams
- Prepared regulatory submissions including consent forms, drug and device documentation, and new project applications
Research Regulatory Specialist
University of Oklahoma Health Sciences Center
Oklahoma City, OK
06.2016 - 04.2018
- Maintained regulatory compliance for OB/GYN research studies
- Submitted new studies and modifications to the IRB
- Supported principal investigators and research nurses with regulatory requirements
- Managed regulatory documentation with internal and external sponsors
- Submitted clinical trial and confidentiality agreements to the Office of Research Administration
Research Compliance Specialist
University of Oklahoma Health Sciences Center
Oklahoma City, OK
01.2015 - 06.2016
- Supported Maternal Fetal Medicine research protocols
- Prepared regulatory submissions, continuing reviews, and inactivation documentation
- Maintained contracts and regulatory files
- Performed data entry and regulatory filing for sponsored research studies
Education
Master of Health Administration (MHA) -
Purdue University
West Lafayette, IN05-2018
Skills
- Auditing expertise
- Regulatory research and submissions
- Interpersonal skills
- Global regulatory compliance
- Interpersonal communication
- Quality assurance
Timeline
Senior Regulatory Coordinator-Regulatory Manager
Northwestern University
12.2022 - Current
Clinical Operations Specialist
Hollister Incorporated
01.2021 - 12.2022
Senior Regulatory Coordinator
Aerotek (Northwestern University Assignment)
01.2020 - 10.2020
Clinical Regulatory Research Coordinator
Rush University Medical Center
04.2018 - 01.2020
Research Regulatory Specialist
University of Oklahoma Health Sciences Center
06.2016 - 04.2018
Research Compliance Specialist
University of Oklahoma Health Sciences Center
01.2015 - 06.2016
Master of Health Administration (MHA) -
Purdue University