Clinical Research Data Specialist I

University of Southern California • Los Angeles, CA

395d • $58,074 - $75,629

About The Position

The Clinical Research Data Specialist I position at the University of Southern California (USC) involves managing clinical trials data, ensuring accuracy and compliance with research regulations. The role requires extracting and entering clinical data from medical records, maintaining communication with sponsors, and supporting quality assurance efforts. This position is essential for the successful execution of clinical research studies, particularly those sponsored by the National Cancer Institute (NCI) and other external entities.

Requirements

• Associate's degree or combined experience/education as substitute for minimum education.
• Minimum 6 months of experience in a related field.
• Requires good attention to detail with prior data entry experience.
• Some knowledge of medical terminology.

Nice To Haves

• Prior experience as a Data Manager in a clinical trials setting.

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).
• Interfaces with sponsors of externally sponsored trials and provides timely data entry.
• Plans and organizes monitoring visits and responds to inquiries.
• Performs follow up for study patient survival by reviewing medical records and contacting other institutions for data.
• Interacts closely with quality assurance teams to ensure data accuracy on Clinical Research Forms (eCRFs/CRFs).
• Discerns basic data discrepancies/protocol violations and assists in obtaining outside documents and study specimen procurement.
• Attends new protocol start-up orientations and completes required protocol specific training.
• Assists in preparation of audits of assigned studies such as NCI, 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.

Benefits

• Competitive hourly rate ranging from $27.92 to $36.36.
• Commitment to diversity and equal opportunity in employment.

What This Job Offers

• Job Type: Full-time
• Industry: Educational Services
• Education Level: Associate degree