Georgetown University's Lombardi Comprehensive Cancer Center Clinical Trials Office (CTO) requires a Research Data Coordinator 1 to manage data for phase I, II, and III oncology clinical trials, ensuring accuracy, compliance, and efficient data collection and resolution of queries.
Requirements
- collection of data from source documents and medical records and completion of case report formsper sponsor requirements.
- 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.
- Ensures accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates.
- Works in compliance with Human Subject Protection regulations, patient confidentiality/HIPAA requirements, and Good Clinical Practice.
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 formsper sponsor requirements.
- 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.
- Ensures accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates.
- Provides support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit.
Other
- Ability to work independently and function within a team.
- Strong attention to detail.
- Reliable and able to prioritize competing responsibilities.
- Maintains confidentiality standards for all potential and enrolled study participants; and complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
- Hybrid 3 Days
