Clinical Research Data Coordinator II- Winship Cancer Institute

Emory University•Brookhaven, GA

12d•Onsite

About The Position

The Data Coordinator II supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. This role is responsible for facilitating initial visits with study subjects, designing, building, and maintaining the functional operations of the database to ensure accuracy and appropriate usage. The position also involves increasing database functionality to meet customer needs, managing complex data acquisition and tracking projects, analyzing subject data for study entrance, ensuring data is entered into the Electronic Data Capture (EDC) system per sponsor contract expectations, and facilitating study monitoring visits while ensuring prompt resolution of all study-related queries.

Requirements

Bachelor 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.

Nice To Haves

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

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 manage all aspects of clinical data management, including the creation and collection of source documents, completion of case report forms, and tracking and reporting of serious adverse events.
Review and analyze information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract data for assigned research protocols.
Accurately capture and enter data into clinical trial databases within timelines set by study sponsors or CTO, and collect/maintain complete records and metrics on each research study participant.
Consolidate clinical data and prepare reports for investigators as needed.
Assist in the review and evaluation of potential research studies and communicate effectively with CTO management and leadership regarding project feasibility.
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 support and 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, and report/address findings.
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 database) for research coordination and data management.
Provide support to Winship’s Informatics team in developing and improving research information systems.
Assure ongoing compliance with all departmental, institutional, and federal requirements and regulations, and department policies.
Maintain controls to assure accuracy, completeness, and confidentiality of research data.
Maintain confidentiality standards for all potential and enrolled patients and comply with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
Perform other duties as assigned.