Clinical Research Regulatory Specialist
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.Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Updates all databases, and regulatory binders with information pertinent to studying milestone progress. Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies, pharmaceutical companies, principal investigators and colleagues.JOB ACCOUNTABILITIES:Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Submits protocols and supporting documents to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies.Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Manages and maintains CISO electronic regulatory files, including staff resumes, licenses, training certificates, equipment receipts, investigation logs, etc. Reviews documentation as needed to support regulatory filings, and maintains research files and documentation required by regulations.Works with senior team members to support and facilitate clinical research. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Interacting with research investigators and staff throughout the process, from helping activate study and research trials to escalating problems and issues, as needed. Provides support and clinical-specific training to staff, maintaining and improving quality assurance training and development programs as needed.Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external spreadsheets, and study electronic systems.Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies...