Abby Ready
Roeland Park,KS
Summary
With over eight years in clinical research, I've advanced from a Clinical Research Coordinator to pivotal roles in Regulatory Affairs and Quality Assurance. As a Quality Assurance Manager at The University of Kansas Cancer Center, I ensure protocol compliance and facilitate internal and help manage external audits. My comprehensive experience spans FDA interactions, CAPA plans, and team training, solidifying my expertise in driving quality and compliance in clinical research.
Overview
8
8
years of professional experience
Work History
Quality Assurance Manager
The University of Kansas Cancer Center
02.2023 - Current
- Perform internal audits of Investigator Initiated Clinical Trials (IITs) ensuring protocol compliance, adherence to Clinical Trials Office SOPs, GCP, and the relevant Institutional and Regulatory guidelines
- Collaborate with key stakeholders including Principal Investigators, CTO Project Directors, and study teams to address audit concerns
- Facilitate both onsite and remote external audits in collaboration with pharmaceutical company QA auditors, CRO auditors, and other academic institution QA teams
- Act as the primary liaison for internal and external audits, including FDA and other Regulatory agency inspections
- Lead staff training, mentoring, and coaching to ensure adherence to organizational policies and procedures
- Serve as a Quality Assurance resource, providing solutions to issues within the KU Cancer Center
- Attend SIVs and kick-off meetings, representing quality assurance objectives
- Handle CAPA requests and provide support to the Data Safety Monitoring Committee Coordinator by generating and reviewing reports, creating meeting agendas, and participating in quarterly meetings
- Fulfill additional duties as assigned
Regulatory Affairs Manager (Contract)
Spectrum Clinical Research
11.2022 - 02.2023
- Prepare document packages for regulatory submissions
- Provide clinical support for Data Management team
- Assist in Quality Assurance by performing quality control audit procedures
- Author or revise study source and internal SOPs
Sr. Regulatory Affairs Manager
Collective Medical Research
01.2020 - 09.2022
- Responsible for all staff onboarding, development, delivery, and tracking of all regulatory documentation, training, and study budgets
- Participated in weekly meetings for updates, reviewed new training protocols and documents
- Facilitated routine internal study and regulatory audits
- Participated in all PSSVs and SIVs
- Coordinated the preparation and submission of new studies to appropriate committees, including the IRB, WIRB, CIRB, and other committees, as necessary, including drafting and/or editing of the ICF and study contracts
Regulatory Affairs Manager
Phoenix Medical Research
12.2016 - 01.2020
- Led pre-study, site qualification, study initiation, monitoring visits, and study close out activities with Sponsors
- Served as the main contact for any FDA, Regulatory, and EDC concerns
- Collaborated with the PI and Sub-I on developing SOPs and guidelines to maintain training requirements for the research team and other project-specific compliance support as assigned (e.g., CAPA Plans, site activations, and mock audit inspections.)
Clinical Research Coordinator
Phoenix Medical Research
12.2015 - 12.2016
- Screened patients for study participation e.g., reviewed the medical record, collaborated with Sub-I and PI to ICF
- Assured synchronization of study visits, procedures, obtained labs, managed the progress of study participants through protocol from start to finish
Education
Bachelor of Arts - Sport Management
Wichita State University
Wichita, KS12.2023
Skills
- Quality Systems
- Internal Audits
- External Audits
- Quality Control Tests
- Staff Training and Development
- IRB Interface experience
- Regulatory Submissions
- Project Management
- Regulatory Affairs
- Medical Terminology
- FDA Knowledge
- GCP Certified
- IATA Certified
- WIRB-Copernicus IRB
- Data Management
Timeline
Quality Assurance Manager
The University of Kansas Cancer Center
02.2023 - Current
Regulatory Affairs Manager (Contract)
Spectrum Clinical Research
11.2022 - 02.2023
Sr. Regulatory Affairs Manager
Collective Medical Research
01.2020 - 09.2022
Regulatory Affairs Manager
Phoenix Medical Research
12.2016 - 01.2020
Clinical Research Coordinator
Phoenix Medical Research
12.2015 - 12.2016
Bachelor of Arts - Sport Management
Wichita State University
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