JOB SUMMARY:Â Â Works closely with the Regulatory Manager III, supporting principal investigators for the Clinical Investigations Support Office. Leads high-quality compliance reviews and coordinates all CISO work to shepherd protocols and open studies in a timely manner. Removes obstacles from study activation, influencing timely Institutional Review Board (IRB) submissions. Liaises with sponsors and agencies to ensure compliance with all applicable local, state, and federal regulations, statutes, and laws, resolving issues and problems, negotiating compromises, and proposing alternatives and recommendations to facilitate and expedite research. Maintains awareness of new and updated rules and regulations, alerting appropriate staff to changes, and ensuring appropriate interpretation and application to new and existing studies and trials.
Works closely with the Clinical Research Regulatory Manager, supporting principal investigators for the Clinical Investigations Support Office. Ensures regulatory compliance for multiple clinical trials, Initiating, revising, and overseeing all regulatory aspects of study opening process. 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. Conducts site initiation visits (SIV) and close-out visits.
Prioritizes and manages own workload, and reports progress regularly to assistant director and team manager(s) as needed or requested. Creates and provides solutions to problems, reviewing processes and suggesting improvements. Escalates problems and issues, as needed.
Oversees maintenance of CISO electronic regulatory files, clinical trial management systems, and binders with information pertinent to studying milestone progress, including but not limited to: IRB databases, internal and external spreadsheets, and study electronic systems. Reviews documentation to support regulatory filings. Prepares annual progress reports for IRB renewal of ongoing studies.
Liaises with sponsors and agencies to ensure compliance with all applicable local, state, and federal regulations, statutes, and laws. As requested and/or required by sponsors, participates in monitoring visits.
Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Alerts appropriate staff to changes, and ensures appropriate interpretation and application to new and existing studies and trials. Maintains compliance with good clinical practice (GCP) guidelines, patient confidentiality (HIPAA), and any other applicable laws.
Participates in KSOM centralized activities to support and promote research regulatory requirements. Participates in CISO educational efforts, helping ensure highest quality research and protection of human subjects. Completes and submits external and reportable adverse event reports according to CISO and sponsor specific requirements. Approves 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.
Minimum Education:Bachelor's degreeCombined experience/education as substitute for minimum educationMinimum Experience:2 yearsMinimum Field of Expertise:Two yearsâ 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. Participates in process management activities. Ability to provide both detailed information as well as summaries to management-level individuals and groups, with experience presenting ideas and solutions in non-technical, business-friendly terms. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and diverse individuals and groups. Experience with office management communication software/tools (e.g. Google suite, Slack, Skype).
Internal Number: REQ20082967
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.