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.
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 including the IRB and Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws.
Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies (including monitors), principal investigators and colleagues. Works with clinical trial coordinators, research staff and investigators to further communications, helping remove obstacles impeding trial progress.
Participates in KSOM centralized activities to support and promote research regulatory requirements. Coordinates with and assists other CISO staff and departments with educational efforts, helping ensure highest quality research and protection of human subjects. Identifies compliance training and educational needs, coordinates the reporting of serious adverse events and protocol deviations, and proposes, completes, and submits amendments to protocols and trial forms and documentation, as needed.
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.
Preferred Education: Bachelor's degree
Preferred Experience: Three years
Preferred Field of Expertise: Three yearsâ experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced
knowledge of regulations governing human research.
Minimum Education:Bachelor's degreeCombined experience/education as substitute for minimum educationMinimum Experience:2 yearsCombined education/experience as substitute for minimum experienceMinimum Field of Expertise:Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICH-GCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and diverse individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g. Google suite, Slack, Skype).
USC’s Viterbi School of Engineering has been one of the economic engines in Southern California and a vital hub in the California economy. The technical innovations and ideas generated by the Viterbi faculty and research community have resulted in countless innovations, many becoming the foundations for new companies, products and services. The thousands of students graduating each year bring new ideas and vitality to companies in California and beyond. With an annual research budget exceeding $205M each year, more than 46 research centers and institutes, more than 180 faculty members, 7,800 students and over 60,000 impassioned alumni world-wide, the Viterbi School is addressing some of the world’s great challenges.