This is a full time staff position with an annual compensation of $75,968.95/year. We are seeking a clinical research regulatory specialist to assist with the development and management of an NIH RF1-grant funded clinical trial in which individuals with stroke will be enrolled and participate in study activities over the course of one year. The candidate will manage and support day-to-day clinical research operations, including participant recruitment, scheduling, data collection, study visit coordination, data entry and verification, staff training, and communications. The candidate will also oversee laboratory resource utilization by overseeing supply procurement, inventory control, and general clinical laboratory safety. The candidate will also maintain complete and accurate clinical research records, study files, training records and laboratory documentation, ensuring all activities comply with federal and institutional guidelines.

Minimum Education:

Bachelor's degree Additional Education Requirements Combined experience/education as substitute for minimum education

Minimum Experience:

2 years Additional Experience Requirements Combined experience/education as substitute for minimum work experience

Minimum Skills:

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 (ICHGCP), 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 varied 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).

Preferred Education:

Bachelor's degree or Masters degree in a life science field or related, with specific experience in clinical research and lab management.

Preferred Experience:

3 years in clinical research compliance, regulatory research and/or operations in the academic or private sector

Preferred Skills:

Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research. USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at (213) 821-8100, or by email at uschr@usc.edu. Inquiries will be treated as confidential to the extent permitted by law. Notice of Non-discrimination Employment Equity Read USC's Clery Act Annual Security Report USC is a smoke-free environment Digital Accessibility If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser: https://wd5.myworkday.com/usc/d/inst/1$9925/9925$150746.htmld Keck Medicine of USC is the University of Southern California's medical enterprise, one of only two university-based medical systems in the Los Angeles area. Keck Medicine combines academic excellence, world-class research and state-of-the-art facilities to provide highly specialized care for some of the most acute patients in the country. Our internationally renowned physicians and scientists provide world-class patient care at Keck Hospital of

USC, USC

Norris Cancer Hospital, USC Verdugo Hills Hospital, USC Arcadia Hospital and more than 100 unique clinics in Los Angeles, Orange, Kern, Tulare and Ventura counties. Keck Medical Center of USC, which includes Keck Hospital and USC Norris Cancer Hospital, is among the top 50 hospitals in the country in 8 specialties, as well as the top three hospitals in metro Los Angeles and top 10 hospitals in California, according to U.S. News & World Report's 2024-25 Best Hospitals rankings. Application Help & Benefits If you need help during the application process, see our application help. For more information about our benefits, see What We Offer. Don't see the dream job you are looking for? Drop off your contact information and resume and we will reach out to you if we find the perfect fit!