Oncology Clincal Data Specialist - Cancer Research - Simmons Cancer Research 11/14/2019
UT Southwestern Medical Center
JOB DESCRIPTIONAPPLY EXPERIENCE AND EDUCATION
Associate's degree in science, business administration, or a related field, and (1) one year of experience in research or clinical healthcare in an Oncology setting;
OR, high school diploma or GED, and three (3) years of experience in research or clinical healthcare, to include at least one (1) year of Oncology experience, required.
Provide Data Management Support. Request records from outside facilities for referred patients or active research subjects. Assist with Velos entry for new subjects & status changes. Assist in reporting protocol deviations in Velos and to the IRB if required. Assists in updating research related calendars, spreadsheets and databases as needed.
CRF Completion. Transfers data from source documents and inputs information in the electronic or paper case report forms. Answers queries, makes corrections to CRF's, IND safety report entry and reporting through eIRB Central review, if required:
Sends all required reports, scans, blood, and/or tissue to sponsor as required. Sponsor/CRA management, schedule and participate in monitor visits. May processes/ship lab specimens. Conducts tasks for long term follow up and non-therapeutic trials when needed.
Works under moderate supervision to provide administrative services for compilation of data resulting from patient-care oncology research studies. Responsible for gathering and coordinating statistical information and treatment data for research studies.
Serves to provide overall data management support for multiple oncology research projects. Obtains and submits confidential information to assist in research subjects' management in accordance with regulations.
Identifies inclusion/exclusion criteria, reads medical records and enters data on new subjects if they meet registration requirements in research study. May obtain informed consent from subjects and provide protocol related education. May include performing the IWRS/IVRS call to register and enroll subjects.
Ensures data in clinical trials management system is up to date and current for research participants.
Assists in the reporting of adverse events, protocol violations or other reportable events in eIRB and assists with follow-up of events, obtaining records and updating data as needed in eIRB.
Assists coordinators, nurses and other research personnel in updating calendars, spreadsheets and databases for subject tracking as needed.
Gathers and reviews source documentation and extracts pertinent data. May meet with coordinators, nurses, and/or physician investigators to confirm or clarify necessary data points.
Completes case report forms as assigned and in accordance with data management guidelines provided by the study sponsor. This involves transferring data from source documentation to electronic or paper case report forms with attention to sponsor deadlines.
Gathers source documentation and completes responses to data queries. Enters corrected data into case report forms or other query databases as appropriate.
Confers with the study team to resolve data discrepancies and queries.
May assist with preparation of annual or terminal summary for each research study as well as other required information for Institutional Review Board.
May provide training and expertise to non-Oncology level clinical data specialists.
May conduct other types of research tasks related to ongoing clinical trials for long term follow-up participants and non-therapeutic trials. Limited tasks for therapeutic clinical trials may also be assigned as appropriate for experience.
Assist in the scheduling of sponsor and internal or external monitoring/auditing visits as required. Works with other departments to ensure visits are scheduled and conducted smoothly.
Manages supply inventory for clinical trials and ensures expired supplies are discarded and adequate supplies are on hand.
**Other Duties: Performs other duties as assigned.
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information
UT SOUTHWESTERN MEDICAL CENTER IS COMMITTED TO AN EDUCATIONAL AND WORKING ENVIRONMENT THAT PROVIDES EQUAL OPPORTUNITY TO ALL MEMBERS OF THE UNIVERSITY COMMUNITY. IN ACCORDANCE WITH FEDERAL AND STATE LAW, THE UNIVERSITY PROHIBITS UNLAWFUL DISCRIMINATION, INCLUDING HARASSMENT, ON THE BASIS OF: RACE; COLOR; RELIGION; NATIONAL ORIGIN; SEX; INCLUDING SEXUAL HARASSMENT; AGE; DISABILITY; GENETIC INFORMATION; CITIZENSHIP STATUS; AND PROTECTED VETERAN STATUS. IN ADDITION, IT IS UT SOUTHWESTERN POLICY TO PROHIBIT DISCRIMINATION ON THE BASIS OF SEXUAL ORIENTATION, GENDER IDENTITY, OR GENDER EXPRESSION..