Clinical Research Data Specialist I

University of Southern California; Los Angeles (CA); On-site; USD 37,000 - 47,000; Full time

Job summary

University of Southern California is seeking a motivated Data Manager to support clinical trials data management. The role involves reading and extracting data from medical records, entering data into eCRFs/CRFs, and maintaining regulatory compliance for SAEs and study procedures.

You will interact with trial sponsors and QA teams, ensure data accuracy, and assist with audits for NCI, FDA, and pharmaceutical studies. A strong eye for detail and knowledge of medical terminology are essential.

Qualifications

• Reads and understands clinical data from medical records and enters required data into eCRFs/CRFs.
• Maintains current knowledge of research regulations including SAE reporting and protocol compliance.
• Interfaces with sponsors of externally sponsored trials and coordinates data entry and monitoring visits.
• Performs follow-up on study patient survival by reviewing records and obtaining data from other institutions when needed.
• Collaborates with quality assurance to ensure data accuracy on eCRFs/CRFs prior to submission for NCI sponsored and other studies.
• Participates in protocol start-up orientations and completes required protocol-specific training.
• Assists in audits for NCI, FDA and pharmaceutical studies.

Responsibilities

• Extracts and enters clinical data from medical records into eCRFs/CRFs.
• Ensures data confidentiality, accuracy and secure access to records.
• Supports audits and quality checks for trial data integrity.

Skills

Data entry

Medical terminology

Attention to detail

Clinical trials data management

Education

Associate's degree

Job description

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

The hourly rate range for this position is $26.77 - $34.32. 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.

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.

USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the