Research Data Coordinator 1

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 Research Data Coordinator 1 position is responsible for data management for phase I, II, and III oncology clinical trials conducted within the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC).  This position performs all duties in accordance with all applicable laws and regulations. Adheres to Georgetown University Medical Center’s philosophies, policies, and SOPs. Works in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice.

Additional duties include, but are not limited to:

• Responsible for supporting all aspects of clinical research data management for clinical trials conducted in the LCCC Clinical Research Management Office (CRMO), including collection of data from source documents and medical records and completion of case report forms per sponsor requirements. 

• Responsible for trials of varying complexity and disease indication.

• Work collaboratively with trial stakeholders and internal study teams (physicians, Regulatory team, Study Coordinators, nursing staff, Research Laboratory Technicians, and Research Pharmacy team).

• Review and analyze information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for all assigned research protocols including, but not limited to, industry, national, and investigator-initiated studies.

• Accurately capture data in electronic or paper Case Report Forms (eCRFs/CRFs) adhering to contractual timelines and site Standard Operating Procedures (SOPs).

• Ensure query resolution with proper physician and clinical study team oversight within site- and sponsor-specific time requirements.

• Request and upload radiological images into sponsor-provided imaging platforms according to each study protocol.

• Resolve imaging-related queries with the assistance of clinical study team.

• Collect and organize source documents in electronic and paper format according to site policies.

• Ensure accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates. Interface with study team members to resolve discrepancies.

• Schedule sponsor monitoring and study close-out visits.

• Provide support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit.

• Communicate appropriately with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members.

• Collaborate closely with physicians and Study Coordinators to maintain protocol integrity.

• Attend protocol-related training and complete all required study training in the required timeframe.

• Prepare for and participate in site initiation visits.

• Assure ongoing compliance with all departmental, institutional, and federal requirements and regulations. Maintain controls to assure accuracy, completeness, and confidentiality of research data.

• Maintain confidentiality standards for all potential and enrolled study participants; comply with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.

• Other duties as assigned.

Work Interactions

• Clinical Research Manager

• Disease Group members: Principal Investigators, Physicians, Clinicians

• Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians

• External department clinicians and staff: Infusion Nurses, Oncology Pharmacists, hospital staff

• Clinical trial sponsors, auditors, and study monitors

Requirements and Qualifications

• High School Diploma or GED required.

• Up to two (2) years of related experience required.

•  Strong candidates exhibit: