Regulatory Affairs Technician
Oklahoma City, Oklahoma, Us
-Ensures Stephenson Cancer Center (SCC) research is reported to the NCI in accordance with requirements set forth by the NCI, Food and Drug Administration (FDA), university, sponsors, Institutional Review Board (IRB), departmental SOPs, and other regulatory bodies.-Conducts quality assurance checks to identify outliers, missing and/or conflicting data, and addresses and rectifies those discrepancies.-Ensures accurate and timely reporting of all SCC interventional and non-interventional trials conducted on oncology patients for the SCC Cancer Center Support Grant (CCSG). -Responsible for timely, accurate data reporting within our Clinical Trial Management System (CTMS) for Data Table 4 (DT4) requirements and CCSG renewals. Serves as point of contact for the NCI on behalf of SCC. Collaborates with SCC Executive Leadership for CCSG write-ups, reports, and future renewals.-Provides guidance and instruction to research personnel on regulatory affairs requirements and procedures.-Supports Research staff in maintaining compliance with study specific training requirements.assists with collection of required documentation from research sites in accordance with FDA and trial sponsor specifications. Tracks collection process through the regulatory process. -Maintains a paper and/or electronic study trial file. And all clinical trials office staff training files. Continually updates the files and assists with the preparation for audits. -Performs various duties as needed to successfully fulfill the functions of the position.