Clinical Research Data Specialist II

University of Southern California•Los Angeles, CA

1d•Onsite

About The Position

The University of Southern California (USC) is seeking a highly motivated and qualified candidate with experience in clinical trials data management to coordinate and manage clinical data for various phases of clinical studies. This role ensures data is documented and recorded appropriately, reads and understands clinical data from medical records, and assists in obtaining outside documents. The specialist will extract and enter required clinical data into eCRFs/CRFs, notify the PI or Study Coordinator of issues or violations, and act as the primary site contact with the sponsor’s Clinical Research Associate (CRA) for externally sponsored trials. Responsibilities include providing timely data entry, planning and organizing monitoring visits, responding to inquiries, and addressing all queries during and after audits. The role requires maintaining currency of federal regulations governing the protection of human subjects, interacting closely with quality assurance teams to ensure data accuracy, discerning basic data discrepancies/protocol violations, and performing follow-up for study patient survival by reviewing medical records. The specialist will also contact other institutions for data on patients hospitalized elsewhere, assist with study specimen procurement and handling, participate in new protocol orientations and training, and prepare for and participate in audits. Additionally, the role involves participating in Quality Assurance Monitoring Committee (QAMC) in-house audits, completing spreadsheets for industry studies for timely sponsor invoicing, and ensuring the confidentiality, accuracy, security, and appropriate access of all data and records. Performs other related duties as assigned or requested.

Requirements

Bachelor's degree, Combined experience/education as substitute for minimum education
1 year experience in clinical trials data management.
Requires strong attention to detail with prior data entry experience.
Basic medical knowledge such as understanding medical terms and familiarity with various assessment criteria.
Strong verbal and written communication skills.
Able to manage time efficiently.

Responsibilities

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 sponsor’s 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.