[Hiring] Senior Clinical Trials Data Coordinator @City of Hope

Role Description

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. Clinical data management is critical to ensuring the accuracy, integrity, and reliability of clinical trial data, supporting regulatory decisions, patient safety, and the advancement of new therapies.

Under the supervision of the Manager, the Senior Clinical Trials Data Coordinator (CTDC) supports complex oncology clinical trials ranging from First-in-Human and Phase I studies through Phase IV. The Senior CTDC is responsible for:

• Coordinating data collection, quality assurance, query resolution, and timely, accurate data entry into electronic data capture (EDC) systems.
• Working closely with Clinical Coordinators and other research staff to interpret research protocols, review medical records, resolve discrepancies, and maintain compliance with study requirements.
• Tracking study activities and financial triggers within the Clinical Trial Management System (CTMS) to support study financial management.
• Collaborating with physicians and clinical teams to review study data, provide updates, and perform peer reviews of data entered into CTMS and EDC systems.
• Supporting the development of data management processes, workflows, and training materials.
• Providing guidance and mentorship to research staff to ensure the highest standards of data quality.

As a successful candidate, you will:

• Enter study data into EMR and CTMS within 3 days of the study visit.
• Build and maintain data standards for all clinical trials.
• Participate in discussions related to and assist in the creation of Electron Data Capture (EDC) builds for Investigator Initiated Studies (IITs).
• Review and resolve queries within 3 days of notification, report as ongoing metric, and maintain notes and data management log.
• Support clinical trial studies from preparation through closeout.
• Ensure source documentation and management of clinical study data is in accordance with FDA regulations, ICH/GCP guidelines and ALCOCA + standards.
• Ensure accuracy and completeness amid vast amounts of complex data and diverse sources; perform quality assurance checks to ensure the accuracy of data entry.
• Communicate with sponsors by phone and/or email to address any protocol issues related to quality of data entry.
• Communicate with clinical coordinators to ensure that patient charts, progress notes as well as Epic Adverse Event module and adverse event documents are organized and accurate.
• Classify adverse events, medications, and medical history using standard dictionaries like MedDRA, CTCAE and WHO-DDE.
• Escalate non-compliant data collection and/or submission.
• Complete study calendars and financial triggers in OnCore CTMS to enable invoicing.
• Participate in departmental required meetings and trainings such as sponsor site visits, protocol updates, Research Committee meetings, etc.
• Collect vital status information for long term survival follow up patients.
• Create source documentation in EPIC related to survival follow-up after each encounter.
• Schedule, coordinate and attend all Interim Monitoring Visits and ensure resolution of any data entry or query issues.
• Participate in audit preparation related to data completeness and quality.
• Attend and participate in Study Initiation Visits.
• Identify and resolve discrepancies or inconsistencies in collected data through data cleaning procedures.
• Generate queries to investigate and resolve data discrepancies with clinical site staff or study investigators.
• Adapt to and leverage new technologies like AI-powered analysis tools and real-world evidence platforms.
• Implement electronic data capture tools such as Archer Ignite Data; become subject matter experts for EMR2EDC platform utilization.
• Prepare monthly data completion status report.
• Assist colleagues in identifying efficiencies and improving processes.
• Participate in process improvement initiatives to streamline workflows, increase efficiencies, reduce redundancies and improve research quality.
• Plan work in a manner that allows timely completion of all assignments and tasks; prioritize work based on deadlines; manage tight timelines.
• Navigate evolving and stringent regulations like ICH-GCP, FDA guidelines, EMA regulations, GDPR, and HIPAA.
• Participate in CAPA creation for data-related deviations and assist team as needed in documenting data-related deviations in Oncore.
• Manage image downloads from source systems to upload to sponsor portals.
• Perform AE abstraction and grading from chart review into EPIC module.
• Validate EPIC AE module builds prior to study activation in collaboration with the clinical coordinator.
• Complete Serious Adverse Event (SAE) follow-ups and resolve SAE queries.
• Upload images, scans and ECG traces into the sponsor portals and manage queries related to the uploads within the portal.

Qualifications

• Bachelor’s degree in Science, Health or related field from an accredited university or related working experience.
• Minimum of 5-7 years research or relevant experience.
• Experience with CTMS, EMR and eRegulatory Systems.
• SOCRA or ACRP Certification within 2 years of employment.
• Preferably three (3) years of oncology-specific research.
• Experience using Excel.

Benefits

• Comprehensive benefits package.