What are the responsibilities and job description for the Clinical Research Data Specialist I position at Keck School of Medicine?
The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the "Trojan Family," which is comprised of the faculty, students and staff that make the university what it is.
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: Associate’s 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
Supervises – Nature of Work
Preferred Field of Expertise: Data Management
Special Instructions to Applicants
Applicant Attachments (Required): Resume
Applicant Attachments (Optional): Cover Letter
The hourly rate range for this position is $27.92 - $36.36. 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 consideration.
The University of Southern California strongly values diversity and is committed to equal opportunity in employment. Women and men, and members of all racial and ethnic groups, people with disabilities, and veterans are encouraged to apply.
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.
Salary : $28 - $36
