Research Data Coordinator 1 - Medical Center

About the position 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 Lombardi Comprehensive Cancer Center Clinical Trials Office (CTO) of the Lombardi Comprehensive Cancer Center (LCCC). Duties include but are not limited to: Supports all aspects of clinical research data management for clinical trials conducted in the Lombardi CTO, including collection of data from source documents and medical records and completion of case report forms per sponsor requirements. Supports trials of varying complexity and disease indication. Works collaboratively with trial stakeholders and internal study teams (physicians, Regulatory team, Study Coordinators, nursing staff, Research Laboratory Technicians, and Research Pharmacy team). Reviews and analyzes 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 captures data in electronic or paper Case Report Forms (eCRFs/CRFs), adhering to contractual timelines and site Standard Operating Procedures (SOPs). Ensures query resolution with proper physician and clinical study team oversight within site- and sponsor-specific time requirements. Requests and uploads radiological images into sponsor-provided imaging platforms according to each study protocol. Resolves imaging-related queries with the assistance of clinical study team. Collects and organizes source documents in electronic and paper format according to site policies. Ensures accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates. Interfaces with study team members to resolve discrepancies. Schedules sponsor monitoring and study close-out visits. Provides support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit. Communicates appropriately with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members. Collaborates closely with physicians and Study Coordinators to maintain protocol integrity. Attends protocol-related training and completes all required study training in the required timeframe. Prepares for - and participates in - site initiation visits. Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations. Maintains controls to assure accuracy, completeness, and confidentiality of research data. Maintains confidentiality standards for all potential and enrolled study participants; and complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations. 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. Other duties as assigned. Work Interactions and Work Mode Designation Clinical Research Manager Disease Group members: Principal Investigators, Physicians, Clinicians Lombardi CTO 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

Responsibilities

• Supports all aspects of clinical research data management for clinical trials conducted in the Lombardi CTO, including collection of data from source documents and medical records and completion of case report forms per sponsor requirements.
• Supports trials of varying complexity and disease indication.
• Works collaboratively with trial stakeholders and internal study teams (physicians, Regulatory team, Study Coordinators, nursing staff, Research Laboratory Technicians, and Research Pharmacy team).
• Reviews and analyzes 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 captures data in electronic or paper Case Report Forms (eCRFs/CRFs), adhering to contractual timelines and site Standard Operating Procedures (SOPs).
• Ensures query resolution with proper physician and clinical study team oversight within site- and sponsor-specific time requirements.
• Requests and uploads radiological images into sponsor-provided imaging platforms according to each study protocol.
• Resolves imaging-related queries with the assistance of clinical study team.
• Collects and organizes source documents in electronic and paper format according to site policies.
• Ensures accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates.
• Interfaces with study team members to resolve discrepancies.
• Schedules sponsor monitoring and study close-out visits.
• Provides support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit.
• Communicates appropriately with pharmaceutical sponsors, study monitors, auditors, physicians, and study team members.
• Collaborates closely with physicians and Study Coordinators to maintain protocol integrity.
• Attends protocol-related training and completes all required study training in the required timeframe.
• Prepares for - and participates in - site initiation visits.
• Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations.
• Maintains controls to assure accuracy, completeness, and confidentiality of research data.
• Maintains confidentiality standards for all potential and enrolled study participants; and complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
• 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.
• Other duties as assigned.

Requirements

• High School Diploma or GED required.
• Up to two (2) years of related experience required.
• Ability to work independently and function within a team.
• Strong attention to detail.
• Reliable and able to prioritize competing responsibilities

Benefits

• Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options.
• You can learn more about benefits and eligibility on the Department of Human Resources website.

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