Georgetown University's Lombardi Comprehensive Cancer Center (LCCC) requires a Research Data Coordinator 2 to manage data for phase I, II, and III oncology clinical trials, ensuring accuracy, compliance, and efficient data flow.
Requirements
- collection of data from source documents and medical records and completion of case report forms per sponsor requirements.
- 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.
- Ensure accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates.
- Assure ongoing compliance with all departmental, institutional, and federal requirements and regulations.
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.
- 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.
- Ensure accuracy of data entered in the Clinical Trials Management System (CTMS) with patient information and key dates.
- Provide support during internal and external monitoring and auditing preparation, including supporting data deficiency corrections and development of corrective actions plans post-audit.
Other
- 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.
