The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the "Trojan Family," which is comprised of the faculty, students and staff that make the university what it is.
We are 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.
Preferred Qualifications
Preferred Education: Associate’s Degree or combined experience/education as substitute for minimum education
Preferred Experience: Prior experience as a Data Manager in a clinical trials setting
Supervises: N/A
Supervises – Nature of Work
Preferred Field of Expertise: Data Management
Special Instructions to Applicants:
Applicant Attachments (Re