Research Data Coordinator 2

Georgetown University•Detroit, MI

23h•$18 - $27•Hybrid

About The Position

The Research Data Coordinator 2 (DC 2) position is responsible for data management for phase I, II, and III oncology clinical trials conducted in the Lombardi Comprehensive Cancer Center (LCCC). This role supports 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. The position handles trials of varying complexity and disease indication and requires collaboration with various trial stakeholders and internal study teams.

Requirements

High School Diploma or GED required.
Three (3) to five (5) 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.

Responsibilities

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.
Assist with training of incoming Research Data Coordinators, including the use of electronic data capture systems, answering data entry questions, and monitoring data entry for new staff and new protocols.
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