Malondy West
Hinsdale,IL
Summary
Clinical Research Associate with 17+ years of experience across CRO and site settings, including oncology trials in high-volume, patient-facing environments. Known for stepping into studies that need structure—cleaning up data, reducing deviations, and getting teams aligned with protocol and regulatory expectations. Strong background in working directly with physicians, coordinators, and patients in community-based research programs. Comfortable reviewing investigator-initiated trials, improving workflows, and supporting teams remotely or on-site to keep studies inspection-ready and moving.
Overview
19
19
years of professional experience
Work History
Clinical Research Coordinator
Ann & Robert H. Lurie Children’s Hospital of Chicago
- Managed day-to-day coordination of clinical trials in a high-volume setting with direct patient interaction
- Performed informed consent, study visits, specimen collection, and source documentation
- Maintained regulatory documents and ensured studies remained audit-ready
- Worked closely with physicians and research staff to support patient care within clinical trials
- Gained strong foundation in patient-facing oncology and complex protocol execution
- Earlier Role
Senior Clinical Research Associate
IQVIA Biotech / PRA Health Sciences / Praxis
01.2007 - Current
- Monitored oncology and complex therapeutic trials across multiple sites, ensuring compliance with protocols, GCP, and sponsor requirements
- Identified and resolved data issues early, improving data quality and reducing query turnaround times
- Led efforts to reduce protocol deviations by working directly with site staff on root cause and corrective actions
- Supported audit and inspection readiness, including preparation, document review, and follow-up on findings
- Reviewed site performance metrics including enrollment, retention, and data entry timelines to keep studies on track
- Worked closely with investigators and coordinators to address study issues in real time and maintain study integrity
- Assisted in development and refinement of study processes, contributing to more consistent site performance
- Provided remote and on-site support to research teams, especially during high-enrollment periods or study startup
- Contract & FTE Roles
Education
Biology / Life Sciences
Loyola University Chicago
Psychological Science
ITT Technical Institute
Skills
- Clinical Trial Monitoring
- Oncology Research
- Protocol Compliance
- Deviation & CAPA Management
- Audit & Inspection Readiness
- Data Quality Review & Query Resolution
- EMR & EDC Systems
- SOP Development & Process Improvement
- Staff Training & Support
- Subject Recruitment & Retention Oversight
- Regulatory Support
- EMR Systems
- Medidata Rave
- Oracle
- CTMS
- Microsoft Office Suite
ADDITIONAL EXPERIENCE
Earlier clinical research roles supporting study coordination, regulatory documentation, and patient care in both hospital and community-based settings.
Timeline
Senior Clinical Research Associate
IQVIA Biotech / PRA Health Sciences / Praxis
01.2007 - Current
Clinical Research Coordinator
Ann & Robert H. Lurie Children’s Hospital of Chicago
Psychological Science
ITT Technical Institute
Biology / Life Sciences
Loyola University Chicago