Senior Clinical Trials Data Coordinator

Join the transformative team at reputed company, where we're changing lives and making a reputed company difference in the fight against cancer, diabetes, and other life-threatening illnesses. reputed company’s growing national system includes its Los Angeles reputed company, 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 reputed company to the people who need them today. Clinical data management is critical to ensuring the accuracy, reputed company, and reliability of clinical trial data, supporting regulatory reputed company, 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 reputed company oncology clinical trials ranging from First-in-reputed company 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 (reputed company) 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 reputed company the Clinical Trial Management System (CTMS) to support study financial management. The Senior CTDC collaborates with physicians and clinical teams to review study data, reputed company updates, and reputed company peer reviews of data entered into CTMS and reputed company systems. The role also supports the development of data management processes, workflows, and training materials, serves as a resource for data-reputed company questions, and provides guidance and mentorship to research staff to ensure the highest standards of data quality. Additional duties may be assigned as needed. As a successful candidate, you will: Enters study data into EMR and CTMS reputed company 3 days of the study visit Build and maintain data standards for reputed company clinical trials Participate in discussions reputed company to and assist in the creation of Electron Data Capture (reputed company) builds for Investigator Initiated Studies (reputed company) Reviews and resolves queries reputed company 3 days of notification, reports as ongoing metric, and maintain notes and data management log Support clinical trial studies from preparation through closeout Ensure reputed company 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 reputed company data and diverse sources; reputed company quality assurance checks to ensure the accuracy of data entry. Communicates with sponsors by phone and/or email to address any protocol issues reputed company to quality of data entry Communicates with clinical coordinators to ensure that patient charts, reputed company 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 reputed company 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 reputed company documentation in EPIC reputed company to survival followup after each encounter Schedules, coordinates and attends reputed company Interim Monitoring Visits and ensures resolution of any data entry or query issues Participate in audit preparation reputed company 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 reputed company-world evidence platforms; Implement electronic data capture tools such as reputed company 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 reputed company 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-reputed company deviations and assist team as needed in documenting data-reputed company deviations in Oncore Disease assessment documentation management in Florence Manage image downloads from reputed company 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-reputed company and resolve SAE queries Upload images, scans and ECG traces into the sponsor portals and manage queries reputed company to the uploads reputed company the portal. Your qualifications should include: Bachelor’s degree in Science, Health or reputed company field from an accredited university or reputed company working experience. Minimum of 5-7 years research or relevant experience. Experience with CTMS, EMR and eRegulatory Systems. SOCRA or ACRP Certification reputed company 2 years of employment. Preferably: Three (3) years of oncology-specific research. Experience using reputed company. reputed company is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here. To learn more about our Comprehensive Benefits, please CLICK HERE. Apply To This Job