Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.
Requirements
Job Overview
The Lombardi Clinical Trials Office (CTO) is a shared institutional resource of the Lombardi Comprehensive Cancer Center (LCCC) at Georgetown University. It provides administrative and clinical operations support for cancer clinical trials conducted by Lombardi investigators.
Reporting directly to the Lombardi CTO Data Team Manager, the Research Data Coordinator 1 is responsible for supporting comprehensive clinical research data management for Phase I, II, and III oncology clinical trials conducted through the Lombardi CTO. This position manages trial data across varying complexity and disease indications, collaborating closely with multidisciplinary research teams to support accurate data collection, case report form completion, and audit readiness.
The Research Data Coordinator 1 reviews and abstracts clinical information from electronic medical records, populates electronic and paper Case Report Forms (eCRFs/CRFs) within contractual and institutional deadlines, facilitates timely query resolution, and maintains data integrity in the Clinical Trials Management System (CTMS; OnCore). Additionally, this role coordinates radiological image uploads, coordinates monitoring visits, and supports audits.
Key responsibilities include, but are not limited to:
Reviewing and analyzing medical records ( e.g., clinic notes, pathology reports, radiology scans, lab results) to extract clinical data for industry, cooperative group (national), and investigator-initiated trials.
Fulfilling all sponsor-required data management deliverables and trial components , including adherence to contractual data entry windows, completion of protocol-specific training, and coordination of sponsor monitoring visits, audits, and study close-out
Accurately capturing clinical research data in electronic or paper Case Report Forms (eCRFs/CRFs) in strict adherence to protocol timelines and site Standard Operating Procedures (SOPs).
Investigating and resolving data queries in collaboration with Principal Investigators, Study Coordinators, and clinical study teams.
Requesting, de-identifying, and uploading digital radiological images into sponsor imaging platforms per study requirements.
Maintaining data accuracy within the Clinical Trials Management System (CTMS; OnCore).
Supporting internal quality monitoring, sponsor monitoring visits, and audits through record preparation and prompt resolution of data deficiencies
The Research Data Coordinator 1 is expected to perform all duties in accordance with applicable laws and regulations and adhere to Georgetown University Medical Center’s philosophies, policies, and SOPs, as well as work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and Good Clinical Practice (GCP) guidelines.
Required Knowledge, Skills, and Abilities Foundational knowledge in:
Medical Terminology: Basic understanding of oncology medical terminology, laboratory values, diagnostic pathology, and clinical visit documentation.
Clinical Research Data Standards: Working knowledge of clinical research principles, Case Report Form (CRF/eCRF) completion, Electronic Data Capture (EDC) systems, and Good Clinical Practice (GCP) guidelines.
Regulatory Compliance & Data Privacy: Knowledge of federal regulations governing human research, with a strong commitment to maintaining strict patient confidentiality under HIPAA regulations.
Attention to…