Sr Clinical Trials Data Coord

Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.

The Senior Clinical Trials Data Coordinator supports complex oncology clinical trials from First-in-Human and Phase I through Phase IV by coordinating data collection, entry, quality assurance, and query resolution to ensure accurate, reliable, and compliant research data. The role involves interpreting research protocols, reviewing medical records, resolving discrepancies, and maintaining study visits and financial triggers within the Clinical Trial Management System (CTMS) aligned with Electronic Data Capture (EDC) systems. Working closely with physicians, clinical coordinators, and research teams, the coordinator ensures timely data reporting, supports adverse event data collection, and contributes to study monitoring and regulatory compliance. Additionally, the role includes performing peer data reviews, assisting in the development of data management plans and workflows, and providing training and guidance to research data staff to maintain high-quality clinical trial data and efficient research operations.

As a successful candidate, you will:

• Enter and manage clinical trial data in EMR, CTMS (OnCore), and EDC systems within required timelines while supporting studies from start-up through closeout.
• Ensure data accuracy, completeness, and compliance through quality checks, data cleaning, and timely resolution of queries.
• Maintain regulatory compliance with FDA, ICH-GCP, ALCOA+, HIPAA, and other applicable guidelines for clinical research data management.
• Collaborate with sponsors, physicians, and clinical coordinators to resolve protocol issues, data discrepancies, and ensure proper documentation.
• Manage adverse event documentation and classification using standard dictionaries such as MedDRA, CTCAE, and WHO-DDE, including SAE follow-up and query resolution.
• Maintain study calendars, financial triggers, and data completion tracking in CTMS to support billing and study financial management.
• Support monitoring visits, study initiation visits, audits, and inspection readiness, ensuring data quality and completeness.
• Contribute to data management improvements by assisting with EDC builds, creating data standards, preparing reports, participating in CAPA and process improvement initiatives, and mentoring peers.