Clinical Research Data Coordinator I - Rollins School of Public Health

Emory University•Atlanta, GA

28d•Onsite

About The Position

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. 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. More experienced Data Coordinators will be assigned to multi-center trials and Winship-held Investigator-Initiated Trials (IITs). 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. Collects and maintains complete records and metrics on each research study participant. Consolidates 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. Provides support during internal and external monitoring and auditing (e.g., sponsor, regulatory agencies) preparation, including supporting data deficiency corrections and development of corrective action plans post audit. Assists in the establishment and maintenance of procedures and systems (i.e., computerized database) for research coordination and data management. Assures 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. Performs other duties as requested. ADDITIONAL JOB DETAILS: The Emory Global Diabetes Research Center (EGDRC) is establishing its AI and Causal Lab and is seeking a highly motivated and detail-oriented Research Data Coordinator to join our team. This position will play a central role in supporting the lab's routine data services and research activities. The successful candidate will be responsible for: Performing data cleaning, management, and quality assurance; Conducting cohort extraction and data preparation for analysis; and Contributing to the development and maintenance of a computable phenotype coding warehouse for the EPIC COSMOS database. This role offers an exciting opportunity to work at the intersection of artificial intelligence, causal inference, and precision public health within a leading global research institution. The Search Committee will accept applications until the position is filled. Interested applicants should submit: (1) a letter of interest, (2) a CV (3) contact information for at least three professional/academic references. Three letters of recommendation will be required for final candidates. NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

Requirements

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

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. More experienced Data Coordinators will be assigned to multi-center trials and Winship-held Investigator-Initiated Trials (IITs).
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. Collects and maintains complete records and metrics on each research study participant. Consolidates 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.
Provides support during internal and external monitoring and auditing (e.g., sponsor, regulatory agencies) preparation, including supporting data deficiency corrections and development of corrective action plans post audit.
Assists in the establishment and maintenance of procedures and systems (i.e., computerized database) for research coordination and data management.
Assures 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.
Performs other duties as requested.
Performing data cleaning, management, and quality assurance
Conducting cohort extraction and data preparation for analysis
Contributing to the development and maintenance of a computable phenotype coding warehouse for the EPIC COSMOS database.