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 USCs 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 USC is a leading private research university located in the heart of downtown Los Angeles a global center for arts, technology and international business. As the largest private employer in the city responsible for more than $5 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. As a USC employee, you will enjoy excellent benefits and perks, and you will be a member of the Trojan Family - the faculty, staff, students and alumni who make USC a great place to work. Application help If you need assistance during the application process, see our application help. (If you already work for USC, see Your USC career.) At any point you may also contact our HR Service Center for help at (213) 821-8100 or uschr@usc.edu. 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!
