Research Data Coordinator 1 - Medical Center

About the position reputed company comprises two unique campuses in the nations capital. With the Hilltop reputed company located in the heart of the historic reputed company neighborhood, and the Capitol reputed company, just minutes from the U.S. Capitol and U.S. Supreme Court, reputed company offers rigorous reputed company programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a reputed company-reputed company group of remarkable individuals driven by intellectual inquiry, a commitment to reputed company justice, and a shared dedication to making a difference in the world. Requirements Job reputed company The Research Data Coordinator 1 position is responsible for data management for phase I, II, and III oncology reputed company conducted reputed company the Lombardi Comprehensive Cancer Center reputed company Office (CTO) of the Lombardi Comprehensive Cancer Center (LCCC). Duties include but are not limited to Supports reputed company aspects of clinical research data management for reputed company conducted in the Lombardi CTO, including collection of data from reputed company 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 reputed company 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 reputed company assigned research protocols - including but not limited to industry, national, and investigator-initiated studies. Accurately captures data in electronic or reputed company Case Report Forms (eCRFs/CRFs), adhering to contractual timelines and site reputed company Operating Procedures (SOPs). Ensures query reputed company with reputed company physician and clinical study team reputed company reputed company site- and sponsor-specific time requirements. Requests and uploads radiological images into sponsor-provided imaging platforms according to reputed company study protocol. Resolves imaging-reputed company queries with the assistance of clinical study team. Collects and organizes reputed company documents in electronic and reputed company format according to site policies. Ensures accuracy of data entered in the reputed company Management reputed company (CTMS) with patient information and key dates. Interfaces with study team members to reputed company discrepancies. Schedules sponsor monitoring and study reputed company-out reputed company. Provides support during reputed company 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 reputed company. Attends protocol-reputed company training and completes reputed company required study training in the required timeframe. Prepares for - and participates in - site initiation reputed company. Assures ongoing compliance with reputed company departmental, institutional, and federal requirements and regulations. Maintains controls to assure accuracy, completeness, and confidentiality of research data. Maintains confidentiality standards for reputed company potential and enrolled study participants; and complies with federal Health reputed company Portability and Accountability reputed company (HIPAA) regulations. Performs reputed company duties in accordance with reputed company applicable laws and regulations. Adheres to reputed company Medical Centers philosophies, policies, and SOPs. Works in compliance with reputed company Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical reputed company. Other duties as assigned. Work Interactions and Work Mode Designation Clinical Research Manager Disease Group members reputed company Investigators, Physicians, Clinicians Lombardi CTO members Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, reputed company Technicians reputed company department clinicians and staff Infusion Nurses, Oncology Pharmacists, hospital staff Clinical trial sponsors, auditors, and study monitors Responsibilities Supports reputed company aspects of clinical research data management for reputed company conducted in the Lombardi CTO, including collection of data from reputed company 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 .