The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute comprised of scientific collaborators committed to advancing the development of new treatments for Alzheimerâs disease (AD) through innovative clinical trials.
The Clinical Research Regulatory Administrator will be responsible for ensuring regulatory compliance for multi-center clinical trials managed by the ATRI at the time of study start up, for the duration of the trial and study closure of the trial.
Job Functions include:
Assist in the development of Protocol and Informed Consent Documents
Preparation of Investigator Initiation Packages (IIPs) for distribution to clinical trial sites
Initiate IRB submission through USC iStar system and Advarra IRB (central IRB) for ATRI clinical trials
Tracking study start-up activities for multi-center clinical trials and providing regular updates to Project Directors, Sponsors and ATRI Leadership
Distribution, collection, processing and tracking of Essential Site Regulatory Documents for all ongoing ATRI clinical trials, including collection of updated Investigator CVs, licenses, GCP and human subjects training certificates.
Specific Job Qualifications:
High attention to detail and strong writing skills are essential.Â
Organizational and follow-through skills are required. Individual must be able to successfully prioritize tasks and complete assignments under strict time deadlines.
Ability to think creatively and problem solve. Work environment encourages individuals to think creatively and to develop systems to continuingly improve day to day functions and tasks using technologies available.Â
Experience with FDA, GCP and OHRP preferred. Previous regulatory experience preferred. Proficiency in Microsoft Office (Word, Excel, Outlook) and Google Drive platforms preferred.
Location: San Diego, CA
Salary: Dependent on experience and education.
Minimum Education: Bachelor's degree. combined experience/education as substitute for minimum education. Minimum Experience: 2 years
USC is the leading private research university in Los Angeles—a global center for arts, technology and international business. With more than 47,500 students, we are located primarily in Los Angeles but also in various US and global satellite locations. As the largest private employer in Los Angeles, responsible for $8 billion annually in economic activity in the region, we offer the opportunity to work in a dynamic and diverse environment, in careers that span a broad spectrum of talents and skills across a variety of academic and professional schools and administrative units. As a USC employee and member of the Trojan Family—the faculty, staff, students, and alumni who make USC a great place to work—you will enjoy excellent benefits, including a variety of well-being programs designed to help individuals achieve work-life balance.