Clinical Research Data Coordinator II - Winship Cancer Institute

About the role

The Data Coordinator II supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. Responsibilities include facilitating initial visits with study subjects, designing and maintaining databases, managing complex data projects, and ensuring accurate data entry and compliance with study protocols.

Responsibilities

• Serve as the Primary Data Coordinator (DC) for complex interventional therapeutic clinical trials, including multi-center trials and WCI-held Investigator Initiated Trials (IITs) in areas such as hematologic cancers, Bone Marrow Transplant (BMT), and Phase I trials.
• Independently handle all aspects of clinical data management, including creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
• Review and analyze medical records (clinic notes, pathology reports, radiology reports, patient questionnaires) to extract data for assigned research protocols, including industry, cooperative group, and investigator-initiated studies.
• Accurately capture and enter data into clinical trial databases within timelines set by study sponsors or the CTO.
• Collect and maintain complete records and metrics for each research study participant.
• Consolidate clinical data and generate reports for investigators as needed.
• Assist in reviewing and evaluating potential research studies and communicate feasibility to CTO management and leadership.
• Attend study team meetings and provide updates on protocol data management activities, including data entry timelines, database locks, unique study requirements, and query management.
• Provide support, ongoing education, and updates to study team members, physicians, nurses, and other healthcare professionals regarding data-related protocol activities.
• Support the Data Team Supervisor in onboarding, training, and quality assurance of DC I positions.
• Serve as a resource to provide guidance to less experienced DCs and other study team members.
• Attend protocol-related training meetings and complete all required study training.
• Liaise with sponsors and the in-house monitoring team, schedule monitoring visits, and address monitoring report findings.
• Lead the DC effort in preparing for and participating in quality control audits to verify the accuracy, completeness, and confidentiality of research data.
• Serve as the lead DC in preparing for internal and external audits (e.g., sponsor, regulatory agencies), addressing identified data deficiencies, and developing corrective action plans post-audit.
• Establish and maintain procedures and systems (e.g., computerized databases) for research coordination and data management.
• Provide support to Winship’s Informatics team in developing and improving research information systems.
• Ensure ongoing compliance with all departmental, institutional, and federal requirements and regulations, as well as department policies.
• Maintain controls to assure accuracy, completeness, and confidentiality of research data.
• Maintain confidentiality standards for all potential and enrolled patients in compliance with HIPAA regulations.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree and at least two (2) years of clinical research data management experience, or
• High School Diploma or GED and at least six (6) years of clinical research data management experience, or
• An equivalent combination of education and experience.

Qualifications

• ACRP/SoCRA (or equivalent) certification preferred within three (3) years of hire.

Schedule

Position tasks are generally required to be performed in-person at an Emory University location. Remote work-from-home options may be granted at department discretion. Emory reserves the right to change remote work status with notice to the employee.