Research Data Associate

Job Responsibilities:

Demonstrates knowledge of the organization’s Core Values and incorporates them into the performance of duties.

Human Subjects’ Research:

1. Responsible for study data entry and query resolution on all assigned simple studies, ensuring data is entered within 1 week or less from the last study visit.
2. Logging study visits into the Clinical Research Management System (CRMS) as they occur to ensure study sponsors are billed for research procedures in a timely and efficient manner.
3. Requesting pathology reports and tissue acquisition required per the study protocol.
4. Coordinate the submission of imaging with the Department of Radiology.
5. Schedules monitoring visits as needed. Coordinates the visit with the study monitor, the CTO Administrative Assistant and Vornado Realty Trust. Requests charts and access to the Electronic Medical Record for study monitors and records all visits in the Data Coordination Unit (DCU) SharePoint. Communicates the change of a monitor, or additional monitors on site to the Business Operations Unit (BOU) for billing purposes.
6. Perform vial assignments and communicates with the study team and investigational pharmacy in a timely and efficient manner. Assists with eligibility review and subject registration with study sponsors, and within the CRMS system.
7. Coordinates the submission of Serious Adverse Events (SAEs) and other reportable events to the Data and Safety Monitoring Committee when applicable, the study sponsor, and the Institutional Review Board (IRB).

Regulatory: Develops a working understanding of Good Clinical Practice (GCP) guidelines, Federal Regulation that govern the conduct of human subjects research as well as Institutional Review Board and institutional policies and procedures related to human subjects research.

Research Activities – Collects patient information for the research project(s). This may include abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc.); abstraction of data for publications, or data collection from outside physicians’ offices.  Uses tools to facilitate data collection (e.g. calendars, schedules, tracking logs, etc.). Updates the database or the case report forms. Assists in reviewing medical history and screening procedures to confirm patient eligibility on protocol.  Reports all adverse events and serious adverse events to applicable agencies. Attends research and committee meetings including DMG Research Meetings and Data and Safety Monitoring Committee Meetings.

Clinical Competency:  Develops an understanding of medical terminology in the oncology field. Navigates and understands how to extract information from the Electronic Medical Record independently.  Assist CCU staff in maintaining a follow up calendar ensuring all survival follow up assessments are completed per the protocol.

Reporting and Analysis – Gathers and compiles data and assists in consolidating/analyzing data for presentation to sponsoring and regulatory agencies.  Provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed.  Conduct primary analysis to data collected. Formulates, prepares database and generates preliminary measurement reports for review by the PI.

Participates in special projects and performs other duties as required.