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Clinical Research Data Specialist I

Cancer Center CISO Los Angeles, California

Clinical Investigations Support Office (CISO) at USC Norris Comprehensive Cancer Center is looking for a highly motivated and qualified candidate with experience in clinical trials data management. 

The following are the specific job functions:

•    Reads and understands clinical data from medical records. Extracts and enters required clinical data from medical records and patient research charts/reports to Clinical Research Forms (eCRFs/CRFs).

•    Maintains currency of research regulations including rules concerning reporting of Serious Adverse Events (SAEs) and violations with department training and feedback.

•    Interfaces with sponsors of externally sponsored trials. Provides timely data entry, plans and organizes monitoring visits and responds to inquiries.

•    Performs follow up for study patient survival by reviewing medical records. Contacts other institutions for data on patients hospitalized at other institutions.

•    Interacts closely with quality assurance teams to ensure data accuracy on Clinical Research Forms (eCRFs/CRFs) prior to submission for in-house, National Cancer Institute (NCI) sponsored and Cooperative Group studies. Discerns basic data discrepancies/protocol violations. Assists in obtaining outside documents and study specimen procurement and handling.

•    Attends new protocol start-up orientations. Completes required protocol specific training.

•    Assists in preparation of audits of assigned studies such as National Cancer Institute (NCI), Food and Drug Administration (FDA) and pharmaceutical audits.

•    Completes spreadsheets for industry studies in real time to ensure sponsor is invoiced appropriately and timely.

•    Ensures confidentiality, accuracy, security and appropriate access of all data and records.

•    Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.


Minimum Education: Associate's degree, Combined experience/education as substitute for minimum education
Minimum Experience: 6 months
Minimum Field of Expertise: Requires good attention to detail with prior data entry experience. Some knowledge of medical terminology.



REQ20048095 Posted Date: 08/17/2017 - Thru date - 11/30/2017

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