Senior Clinical Trials Data Coordinator

City of Hope

23h

About The Position

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. 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. High-quality data enables meaningful analysis, helps identify and resolve issues promptly, and supports efficient financial management of clinical research studies. 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, the Senior CTDC independently interprets research protocols, reviews medical records, resolves discrepancies, and helps maintain compliance with study requirements. Responsibilities include tracking study activities and financial triggers within the Clinical Trial Management System (CTMS) to support study financial management. The Senior CTDC collaborates with physicians and clinical teams to review study data, provide updates, and perform peer reviews of data entered into CTMS and EDC systems. The role also supports the development of data management processes, workflows, and training materials, serves as a resource for data-related questions, and provides guidance and mentorship to research staff to ensure the highest standards of data quality. Additional duties may be assigned as needed.

Requirements

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.

Nice To Haves

Three (3) years of oncology-specific research.
Experience using Excel.

Responsibilities

Enters 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)
Reviews and resolves queries within 3 days of notification, reports 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.
Communicates with sponsors by phone and/or email to address any protocol issues related to quality of data entry
Communicates 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; Classifying adverse events, medications, and medical history using standard dictionaries like MedDRA, CTCAE and WHO-DDE.
Escalates non-compliant data collection and/or submission
Completes study calendars and financial triggers in OnCore CTMS to enable invoicing
Participates in departmental required meetings and trainings such as sponsor site visits, protocol updates, Research Committee meetings, etc.
Collects vital status information for long term survival follow up patients
Create source documentation in EPIC related to survival followup after each encounter
Schedules, coordinates and attends all Interim Monitoring Visits and ensures resolution of any data entry or query issues
Participate in audit preparation related to data completeness and quality
Attend and participate in Study Initation Visits
Peer Review Process - 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 leveraging 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
Prepares monthly data completion status report
Assists colleagues in identifying efficiencies and improving processes
Participate in process improvement initiatives to streamline workflows, increase deficiencies, reduce redundancies and improve research quality
Plans work in a manner that allows timely completion of all assignments and tasks; Prioritizes 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
Disease assessment documentation management in Florence
Manage image downloads from source systems to upload to sponsor portals
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.