Sr Clinical Trials Data Coord

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.

Qualifications - External Your qualifications should include: Minimum Education Bachelor's degree in Science, Health, or a related field from an accredited university, or equivalent relevant work experience. Minimum Experience: Minimum of 5-7 years of clinical research or related experience. Required Certifications: Completion of Good Clinical Practice (GCP) training within 1 month of employment. Completion of Human Subjects Protection (HSP) training within 1 month of employment. Ability to obtain SOCRA or ACRP certification within 2 years of employment. Systems Knowledge: Experience with Clinical Trial Management Systems (CTMS), Electronic Medical Records (EMR), and eRegulatory systems. City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location. To learn more about our Comprehensive Benefits, please CLICK HERE