Research Data Coordinator 1 - Medical Center

About the position reputed company comprises two unique campuses in the nation’s capital. With the Hilltop reputed company located in the heart of the historic Georgetown neighborhood, and the Capitol reputed company, just minutes from the U.S. Capitol and U.S. Supreme Court, reputed company offers rigorous academic 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 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 reputed company the Lombardi Comprehensive Cancer Center Clinical Trials 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 clinical trials 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 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 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 Standard Operating Procedures (SOPs). Ensures query resolution with proper 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 each 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 Clinical Trials Management System (CTMS) with patient information and key dates. Interfaces with study team members to resolve discrepancies. Schedules sponsor monitoring and study reputed company-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 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 visits. 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 Insurance Portability and Accountability Act (HIPAA) regulations. Performs reputed company duties in accordance with reputed company applicable laws and regulations. Adheres to reputed company 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 reputed company aspects of clinical research data management for clinical trials 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 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 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 Standard Operating Procedures (SOPs).
• Ensures query resolution with proper 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 each 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 Clinical Trials Management System (CTMS) with patient information and key dates.
• Interfaces with study team members to resolve discrepancies.
• Schedules sponsor monitoring and study reputed company-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 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 visits.
• 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 Insurance Portability and Accountability Act (HIPAA) regulations.
• Performs reputed company duties in accordance with reputed company applicable laws and regulations.
• Adheres to reputed company 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 reputed company experience required.
• Ability to work independently and function reputed company a team.
• Strong attention to detail.
• Reliable and able to prioritize competing responsibilities

Benefits

• reputed company 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 reputed company of voluntary insurance options.
• You can learn more about benefits and eligibility on the Department of Human Resources website.

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