CHRISTINE L. MALEY
Chicago,IL
Summary
Clinical research and healthcare advisory professional with 10+ years of experience in study operations, project management, and strategic planning. Skilled in translating complex data into actionable insights that improve operational efficiency, mitigate risk, and support informed decision-making across clients, sites, and cross-functional teams.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
COOK COUNTY HEALTH NCORPS
Chicago, IL
06.2025 - Current
- Created and operationalized SOPs for complex clinical studies, transforming fragmented processes into structured, data-informed workflows that improved coordination, increased efficiency, and eliminated execution gaps affecting patient and study needs.
- Conducted oncology clinical trials in accordance with NCI/NCORP protocols and ICH-GCP, ensuring compliance with protocol, IRB, HIPAA, and regulatory standards while prioritizing participant safety.
- Managed site audits and monitoring visits, documenting findings and implementing corrective actions to maintain audit readiness and uphold data integrity.
- Developed and executed CAPA plans through root cause analysis to address deviations and strengthen study process compliance.
- Led standardized procedures for multi-departmental study execution, leveraging operational analysis to improve adoption, clarify responsibilities, and ensure consistent delivery across non-research clinical staff and external partners.
- Performed source data verification and reconciliation in RAVE, REDCap, and EMR, resolving queries and ensuring timely reporting to sponsors and regulatory bodies.
Clinical Research Associate II, Neurointestinal and Motility Program
ANNE AND ROBERT H. LURIE CHILDREN’S HOSPITAL
Chicago, IL
11.2024 - 05.2025
- Translated clinical research insights into product-oriented solutions, contributing to a prototype focused on improving patient-reported distress tracking and care optimization in GI populations.
- Partnered with clinical, technical, and operational stakeholders to define user needs, validate concepts, and iterate on data-driven solutions aligned with real-world workflows.
- Leveraged mixed-methods data, including qualitative interviews, quantitative outcomes, and site feedback, to inform feature development, usability considerations, and overall product strategy.
- Identified gaps in research and care delivery processes, proposing innovative tools and frameworks to enhance patient monitoring, reporting accuracy, and decision support.
Clinical Research Coordinator, Neurosurgery / Research Assistant, Infectious Disease
UNIVERSITY OF ILLINOIS CHICAGO
Chicago, IL
09.2020 - 09.2024
- Developed SOPs for high-complexity trials involving external teams and internally staffed lab support, applying process analysis to improve usability, coordination, and compliance.
- Oversaw site management activities, ensuring compliance with study protocols and ICH-GCP regulations while improving operational efficiency across internal and external projects.
- Conducted site pre-audits and generated monitoring reports to confirm adherence to institutional regulations.
- Optimized regulatory workflows to improve compliance processes and identify areas for enhancement.
- Managed the Clinical Trial Management System (CTMS) to produce accurate study reports and documentation, ensuring data accessibility for investigators and sponsors.
- Mentored graduate medical students and staff on protocol procedures and data collection standards, fostering a culture of compliance and excellence.
Research Assistant
LIGHTHOUSE INSTITUTE
Chicago, IL
10.2019 - 09.2020
- Supported the design and implementation of quantitative and qualitative research focused on adults with substance use disorders and criminal justice involvement.
- Conducted primary data collection and analysis through interviews, surveys, and focus groups, ensuring accurate data entry and processing.
- Monitored research projects and proposed improvements to enhance participant adherence and overall study outcomes.
Mental Health Counselor
HARTGROVE BEHAVIORAL HEALTH
Chicago, IL
06.2018 - 10.2019
- Participated in interdisciplinary team meetings to review case progression, refine treatment plans, and implement evidence-based interventions.
- Established supportive therapeutic relationships while utilizing behavior management and de-escalation techniques to support client progress.
Youth Counselor
FOUR OAKS, AREA ABUSE SUBSTANCE COUNCIL
Cedar Rapids, IA
08.2017 - 02.2018
- Oversaw clinical, legal, and educational coordination for 20+ adolescents in a structured inpatient environment, ensuring comprehensive treatment and effective discharge planning.
- Delivered group and individual CBT/DBT sessions and drug education, serving as a liaison with clinicians, schools, and law enforcement.
- Developed positive reinforcement programs aimed at improving behavioral consistency and reducing the need for punitive measures.
Senior Consultant
MINDSPRING PARTNERS
Chicago, IL
06.2015 - 08.2017
- Provided recruitment expertise in finance, legal, and IT sectors across various client engagements.
- Managed sourcing, screening, and placement of candidates for mid- to senior-level positions.
- Developed tailored recruiting strategies and advised clients on hiring processes.
Senior Executive Recruiter Associate
REDLINE ASSOCIATES
Chicago, IL
01.2013 - 06.2015
- Secured the highest volume of new business for the firm within 10 months post-promotion by implementing targeted marketing strategies.
- Developed the firm’s SOP to enhance onboarding for new recruiters, standardizing recruitment tactics and improving operational efficiency.
Director of Staffing and Communications
MED STAFF ON-CALL
Chicago, IL
10.2011 - 11.2013
- Directed agency account operations, focusing on staffing, invoicing, training, regulatory compliance, and technology initiatives to enhance operational efficiency.
Education
Bachelor of Arts - Journalism and Psychology
Indiana University
07-2018
Master of Arts - Rehabilitation and Clinical Mental Health Counseling
The University of Iowa
05-2011
Skills
- Clinical Research Operations
- Data Analysis
- SOP Development
- Study Tracking
- Risk Management
- CAPA
- Regulatory Compliance
- IRB Submissions
- Cross-Functional Collaboration
- Protocol Development
- REDCap
- RAVE
- EMR
- CTMS
- SPSS
- Analytical Skills
- Project Management
- Market Research
- Business Acumen
- Consulting
- Site management
- Coordinating site operations
- Project monitoring
- Clinical trial management
- Source document verification
- Project management
- Status reporting
- Report writing
- Research and development
- Data evaluation
- Medical writing
- Reviewing data standards
- Data analysis
- Case report management
- Study monitoring
- Database organization
Certification
- Clinical Research Specialist (CRCC) — University of Illinois Chicago, Jan 2023
- Data Science Specialist — Johns Hopkins University, Baltimore, MD
Timeline
Clinical Research Associate
COOK COUNTY HEALTH NCORPS
06.2025 - Current
Clinical Research Associate II, Neurointestinal and Motility Program
ANNE AND ROBERT H. LURIE CHILDREN’S HOSPITAL
11.2024 - 05.2025
Clinical Research Coordinator, Neurosurgery / Research Assistant, Infectious Disease
UNIVERSITY OF ILLINOIS CHICAGO
09.2020 - 09.2024
Research Assistant
LIGHTHOUSE INSTITUTE
10.2019 - 09.2020
Mental Health Counselor
HARTGROVE BEHAVIORAL HEALTH
06.2018 - 10.2019
Youth Counselor
FOUR OAKS, AREA ABUSE SUBSTANCE COUNCIL
08.2017 - 02.2018
Senior Consultant
MINDSPRING PARTNERS
06.2015 - 08.2017
Senior Executive Recruiter Associate
REDLINE ASSOCIATES
01.2013 - 06.2015
Director of Staffing and Communications
MED STAFF ON-CALL
10.2011 - 11.2013
Master of Arts - Rehabilitation and Clinical Mental Health Counseling
The University of Iowa
Bachelor of Arts - Journalism and Psychology
Indiana University