Clinical Research Data Specialist I

About the role

We are seeking a highly motivated and qualified candidate with experience in clinical trials data management to join the Trojan Family at the University of Southern California, a world-class research university and the largest private employer in the City of Los Angeles.

Responsibilities

• 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, providing timely data entry, planning and organizing monitoring visits, and responding to inquiries.
• Performs follow-up for study patient survival by reviewing medical records and contacts other institutions for data on patients hospitalized elsewhere.
• 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 and assists in obtaining outside documents and study specimen procurement and handling.
• Attends new protocol start-up orientations and completes required protocol-specific training.
• Assists in preparation of audits for 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 sponsors are invoiced appropriately and timely.
• Ensures confidentiality, accuracy, security, and appropriate access of all data and records.
• Performs other related duties as assigned or requested.

Requirements

• Minimum Education: Associate's degree (combined experience/education may 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.

Pay

The hourly rate range for this position is $26.77 - $34.32. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.