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 Training, Education, and Quality Control (TEQC) Manager, the Quality Control Coordinator 1 interfaces with clinical research faculty and staff in the execution and maintenance of a comprehensive cancer clinical research quality control program across LCCC’s NCI Cancer Center Support Grant (CCSG) consortium sites. This position works in close coordination with LCCC consortium clinical research teams as well as the leadership and staff within the Georgetown University Medical Center (GUMC) Office of Research Quality Assurance (ORQA).
The Quality Control Coordinator 1 performs study- and staff-level quality assessments to verify adherence to Lombardi CTO Guidance Documents, joint GUMC and MedStar Health Standard Operating Procedures (SOPs), and applicable federal, state, and institutional regulatory standards. Through proactive quality monitoring and audit support activities, the Quality Control Coordinator 1 plays an essential role in evaluating protocol compliance, supporting staff competency, and promoting audit readiness across all LCCC cancer clinical research studies.
Key responsibilities include, but are not limited to:
Performing quality control assessments and risk-based centralized eligibility reviews for select cancer clinical trials ( e.g., NCTN).
Conducting regular quality reviews within the Clinical Trials Management System (CTMS; OnCore) to assure data integrity and SOP compliance.
Assisting in the coordination, preparation, conduct, and follow-up for internal quality monitoring and external audits across LCCC consortium sites.
Collaborating with ORQA and the TEQC Manager to review audit findings and identify systemic trends to inform future training and educational initiatives.
Assisting with the maintenance of Lombardi CTO Standard Operating Procedures and Guidance Documents to support uniform research practices.
The Quality Control 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
Regulatory & Quality Compliance: Working knowledge of regulations governing clinical research conduct (FDA, Human Subject Protection, Good Clinical Practice [GCP], and International Council for Harmonisation [ICH] guidelines).
Oncology Research Operations: Foundational understanding of medical and clinical research terminology, protocol visit structures, and clinical trial workflows, preferably within oncology therapeutic research.
Quality Assurance Principles: Understanding of quality control reviews, source document verification, centralized eligibility screening, and audit preparation processes.
Attention to Detail & Analytical Skills: Proven ability to review clinical research records accurately, identify protocol discrepancies or compliance gaps, and document findings clearly.
Organization & Time Management: Strong…