Clinical Research Data Coordinator I- Winship Cancer Institute

KEY RESPONSIBILITIES

• Supports and assists in all aspects of clinical data management, protocol data management, including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
• Primary Data Coordinator (DC) for therapeutic and non-therapeutic clinical trials across all disease teams, including complex areas such as hematologic cancers, Bone Marrow Transplant (BMT), Phase I trials, etc.
• Reviews 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, cooperative group, and investigator-initiated studies.
• Accurately captures and enters data into clinical trial databases as necessary, and within timelines set by study sponsors or CTO.
• Collections clinical data and reports for investigators as needed.
• Attends study team meetings and provides updates to study team members regarding protocol data management activities, including data entry timelines, database locks, unique study requirements, and data query management.
• Attends protocol related training meetings and completes all required study training.
• Prepares for and assists with internal quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate.
• Assists in the establishment and maintenance of procedures and systems (i.e., computerized database) for research coordination and data management.
• Affirms ongoing compliance with all departmental, institutional, and federal requirements and regulations.
• Maintains controls to assure accuracy, completeness, and confidentiality of research data.
• Maintains confidentiality standards for all potential and enrolled study participants; complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.

MINIMUM QUALIFICATIONS

• High School Diploma or GED and three years of administrative support experience
• Two years of college in a scientific, health related, or business administration program and one year of admin support or customer service experience
• Licensed as a practical nurse (LPN) and one year admin support or one year of licensed practical nursing experience
• Bachelor's degree, Master's degree, MD or PhD in a scientific, health related or business administration program