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.