JOB DESCRIPTION: The Data Coordinator II, supports the research program within the Clinical Trials Office (CTO) of Winship Cancer Institute (WCI) at Emory University. Responsible for facilitating initial visit with study subject. Designs, builds, and maintains the functional operations of the database, ensuring accuracy and appropriate usage by all internal customers. Increases the functionality of the database to meet the needs of internal customers and members of the department. Manages complex projects related to data acquisition and tracking that are not related to a database. Analyzes subject data in relation to study protocol for entrance into study. Ensures data from source is entered in EDC per Sponsor contract expectations if not sooner. Facilitates study monitoring visits and prompt resolution of all study related queries.
WORK PERFORMED
* 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.
MINIMUM QUALIFICATIONS: 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.
PREFERRED QUALIFICATIONS: Certification/license: ACRP/SoCRA (or equivalent) certification preferred within three (3) years of hire. |
Emory University is dedicated to providing equal opportunities to all individuals regardless of race, color, religion, ethnic or national origin, gender, age, disability, sexual orientation, gender identity, gender expression, veteran's status, or any other factor that is a prohibited consideration under applicable law. |
Human Resources