Clinical Research Data Coordinator II - Winship Cancer Institute

Emory University•Brookhaven, GA

3h•Hybrid

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 aims to increase database functionality to meet the needs of internal customers and department members, manage complex projects related to data acquisition and tracking, and analyze subject data in relation to study protocols for study entrance. The Data Coordinator II ensures data from source is entered into the Electronic Data Capture (EDC) system per sponsor contract expectations and facilitates study monitoring visits, 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

Primary Data Coordinator (DC) for complex interventional therapeutic clinical trials, including multi-center trials and WCI held Investigator Initiated Trials (IITs) in complex areas such as hematologic cancers, Bone Marrow Transplant (BMT), Phase I trials, etc.
Independently responsible for 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.
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, 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. Collects and maintains complete records and metrics on each research study participant. Consolidates clinical data and reports for investigators as needed.
Assists in the review and evaluation of potential research studies and communicates effectively with CTO management and leadership regarding feasibility of proposed projects.
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 query management. Also provides support, ongoing education and updates to study team members, physicians, nurses, and other healthcare professionals regarding data-related protocol activities.
Supports Data Team Supervisor in onboarding, training, and quality assurance of DC I position, as directed by DT Supervisor or Clinical Research Operations Manager (CROM).
Serves as a resource to provide support and guidance to less experienced DCs and other study team members.
Attends protocol related training meetings and completes all required study training.
Liaises with sponsors and the in-house monitoring team, schedules monitoring visits, and addresses monitoring report findings.
Leads the DC effort in preparing for and participating in quality control audits to verify the accuracy, completeness, and confidentiality of research data. Reports and addresses findings as appropriate.
Serves 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.
Establishes and maintains procedures and systems (i.e., computerized database) for research coordination and data management. Provides support to Winship’s Informatics team as they develop and improve research information systems.
Assures ongoing compliance with all departmental, institutional, and federal requirements and regulations and department policies. Maintains controls to assure accuracy, completeness, and confidentiality of research data.
Maintains confidentiality standards for all potential and enrolled patients; complies with federal Health Insurance Portability and Accountability Act (HIPAA) regulations.
Performs other duties as assigned.