The Clinical Investigations Support Office (CISO)Â at USC Norris Comprehensive Cancer Center is looking for a highly motivated and qualified candidate with experience in clinical trials data management.
Specific Job Duties:
Coordinates and manages the clinical data for various phases of clinical study. Ensures data is documented and recorded as appropriate. Reads and understands clinical data from medical records and assists in obtaining outside documents. Extracts and enters required clinical data from medical records and patient research charts/reports into Clinical Research Forms (eCRFs/CRFs). Notifies PI or Study Coordinator of issues or violations.
Acts as primary site contact with sponsorâs Clinical Research Associate (CRA) for externally sponsored trials. Provides timely data entry, plans and organizes monitoring visits and responds to inquiries. Addresses all queries during and after audit for resolution.
Maintains currency of federal regulations governing the protection of human subjects such as Food and Drug Administration (FDA), Good Clinical Practice/International Conference on Harmonisation (GCP/ICH) guidelines, Office of Human Research Protections (OHRP), Health Insurance Portability and Accountability Act (HIPAA), rules concerning reporting of Serious Adverse Events (SAEs) and violations with department training and feedback.
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.
Performs follow up for study patient survival by reviewing medical records. Contacts other institutions for data on patients hospitalized at other institutions.
Assists with study specimen procurement and handling.
Participates and attends internal and external new protocol start-up orientations and completes required protocol specific training.
Prepares and participates in audits of assigned studies such as National Cancer Institute (NCI), Food and Drug Administration (FDA) and pharmaceutical audits.
Participates in Quality Assurance Monitoring Committee (QAMC) in-house audits by reviewing assigned patient chart and reporting on findings as relates to protocol/patient compliance.
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.
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.