"Clinical Research Data Specialist I"

Job Description

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: Associates 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

Preferred Field of Expertise: Data Management

Special Instructions to Applicants

Applicant Attachments (Required): Resume

Applicant Attachments (Optional): Cover Letter

Salary Information

The hourly rate range for this position is $26.77 - $34.13. 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 candidates 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 consideration.

Minimum Requirements

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.

About the Employer

USC is the leading private research university in Los Angeles—a global center for arts, technology and international business. With more than 47,500 students, we are located primarily in Los Angeles but also in various US and global satellite locations. As the largest private employer in Los Angeles, responsible for $8 billion annually in economic activity in the region, we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills across a variety of academic and professional schools and administrative units. As a USC employee and member of the Trojan Family—the faculty, staff, students, and alumni who make USC a great place to work—you will enjoy excellent benefits, including a variety of well-being programs designed to help individuals achieve work-life balance.