Christine Maley

Conduct oncology clinical trials per NCI/NCORP protocols and ICH-GCP, monitoring to ensure protocol, IRB, HIPAA, and regulatory compliance and participant safety. Manage and execute site audits and monitoring visits, documenting findings and corrective actions to ensure audit readiness and data integrity. Lead implementation of CAPA plans using root cause analysis (RCA) to address deviations and reduce recurrence, improving study process compliance.

Clinical Research Associate - COOK COUNTY HEALTH NCORPS - Chicago, IL

(2025-06)

• Conduct oncology clinical trials per NCI/NCORP protocols and ICH-GCP, monitoring to ensure protocol, IRB, HIPAA, and regulatory compliance and participant safety.
• Manage and execute site audits and monitoring visits, documenting findings and corrective actions to ensure audit readiness and data integrity.
• Lead implementation of CAPA plans using root cause analysis (RCA) to address deviations and reduce recurrence, improving study process compliance.
• Support study management and data integrity by coordinating with investigators and clinical teams to align operational activities with protocol requirements.
• Evaluate patient eligibility via detailed chart review and coordination with referring providers and principal investigators to ensure accurate source documentation and protocol adherence.
• Perform source data verification (SDV), source data review (SDR), CRF review and routine data reconciliation in RAVE, REDCap, and EMR; resolved queries and ensured timely reporting to sponsors and regulatory bodies.
• Represent the site at tumor boards and cooperative group meetings (ECOG-ACRIN, WF, Alliance) to assess site feasibility and investigator qualifications, enabling successful trial execution.
• Coordinate patient visits and procedures (imaging, labs, oncology consults) to optimize trial workflow and participant retention.

Clinical Research Coordinator/Associate II - Neurointestinal and Motility Program - ANNE AND ROBERT H. LURIE CHILDREN'S HOSPITAL - Chicago, IL

(2024-11 - 2025-05)

• Facilitated presentations for clinical research teams and investigator meetings, improving cross-functional collaboration and study understanding.
• Managed operations for investigator-initiated, multi-site research projects, implementing REDCap/EDC data collection and maintaining regulatory compliance across sites.
• Composed the entire protocol development lifecycle, ensuring adherence to all relevant guidelines and requirements for regulatory services.
• Developed and executed preventive measures and CAPA to mitigate risks and ensure patient safety throughout pediatric GI clinical trials.
• Provided coaching to regulatory services team members, enhancing compliance and operational efficiency.
• Maintained essential study documents, manuals of procedures, and regulatory submissions; prepared and submitted IRB documentation and updated processes to accommodate protocol amendments, ensuring continuous compliance and audit readiness.
• Led participant recruitment and site coordination (screening, outreach, assent/consent, scheduling, specimen collection), ensuring adherence to site protocols and billing practices.
• Designed recruitment strategies and analytic tools to capture qualitative and quantitative research data for downstream analysis and sponsor reporting.

Clinical Research Coordinator - Neurosurgery - UNIVERSITY OF ILLINOIS, CHICAGO - Chicago, IL

(2021-09 - 2024-09)

Clinical Research Coordinator/Research Assistant - Infectious Disease - UNIVERSITY OF ILLINOIS, CHICAGO - Chicago, IL

(2020-09 - 2021-09)

• Oversaw site management activities, ensuring compliance with study protocols and regulatory requirements.
• Conducted comprehensive site pre-audits and prepared monitoring reports to confirm adherence to ICH-GCP and institutional regulations.
• Applied expertise in health administration to streamline regulatory processes and maintain compliance.
• Managed CTMS to prepare study reports and documentation for investigators, monitors, and sponsors, ensuring study data was current and accessible.
• Coordinated pre- and post-study activities and liaised with internal, external, and third-party regulatory groups to ensure compliance.
• Led subject recruitment, screening, scheduling, testing, and data management for studies including experimental devices, pharmaceutical trials, surgical interventional treatments, and observational research, ensuring accurate source documentation.
• Mentored and trained graduate medical students and staff on protocol procedures, data collection standards, and regulatory requirements.
• Drafted monitoring-ready documentation and responded to sponsor and monitor inquiries to support oversight and inspections.

Research Assistant - LIGHTHOUSE INSTITUTE - Chicago, IL

(2019-10 - 2020-09)

• Assisted in the design, development, and implementation of quantitative and qualitative research for projects involving adults with substance use disorders and criminal justice involvement.
• Performed primary data collection, entry, processing, and analysis for clinical trials, observational studies, and community-based research using interviews, surveys, focus groups, and phone evaluations.
• Supported planning, monitoring, and execution of research projects and proposed procedural and process improvements to enhance participant adherence and study outcomes.

Mental Health Counselor - HARTGROVE BEHAVIORAL HEALTH - Chicago, IL

(2018-06 - 2019-10)

• Collaborated with an interdisciplinary team to review case progression and optimize individualized treatment plans, implementing evidence-based interventions to improve measurable client outcomes.
• Built trusting therapeutic relationships and applied behavior management and de-escalation techniques to support clients' developmental progress.

Youth Counselor - FOUR OAKS, AREA ABUSE SUBSTANCE COUNCIL - Cedar Rapids, IA

(2017-08 - 2018-02)

• Provided individualized care for 20+ adolescents in a structured inpatient environment, overseeing clinical, legal, and educational coordination during treatment and discharge planning.
• Delivered group and individual CBT/DBT and drug education; advised clinicians on psychological health and acted as legal advocate with schools, DCFS, and law enforcement as needed.
• Developed and implemented positive reinforcement programs to improve behavioral consistency and reduce punitive measures.

Senior Consultant - MINDSPRING PARTNERS - Chicago, IL; Denver, CO; Iowa City, IA

(2015-06 - 2017-08)

• Served as one of three principal recruiters providing finance, legal, and IT recruitment expertise across client engagements.
• Managed candidate sourcing, screening, and placement for mid- to senior-level roles.
• Developed client-specific recruiting strategies and advised on hiring processes.

Senior Executive Recruiter Associate - REDLINE ASSOCIATES - Chicago, IL

(2013-01 - 2015-06)

• Secured the most new business for the firm in 10 months after promotion to a full-desk Senior Executive by employing strategic marketing to expand clientele while maintaining placement productivity.
• Created the firm's Standard Operating Procedure to streamline onboarding for new recruiters and trainees, standardizing recruitment tactics and processes.

Director of Staffing and Communications - MED STAFF ON-CALL - Chicago, IL

(2011-10 - 2013-11)

• Oversaw agency account operations including staffing, invoicing, training, regulatory compliance, and technology initiatives.

Master of Arts - Rehabilitation and Clinical Mental Health Counseling - THE UNIVERSITY OF IOWA (2017)

Bachelor of Arts - Journalism and Psychology - INDIANA UNIVERSITY (2011-05)