Clinical Research Associate at University of Southern California San Diego, CA

Overview The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s Disease (AD) through innovative clinical trials. Responsibilities Conduct onsite and remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring visit activities. Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures. Review study data, issue and resolve queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance. Act as main point of contact for assigned clinical sites. Thorough understanding of study protocol and manuals. Work closely with Lead Clinical Monitor/Lead CRA to elevate site compliance issues. Participate in monitoring activities to achieve study milestones. Utilize internal and study specific software and tools. Assist in training new monitors on study specific or onsite procedures as needed. Participate in sponsor, internal, and regulatory audits as needed. Participate in eTMF filing efforts as needed. Experience in AD research is preferred. Up to 50% travel may be required. Qualifications Minimum Education: Bachelor's degree, combined experience/education as substitute for minimum education. Minimum Experience: 2 years. Field of Expertise: Monitoring of clinical trials and medical terminology. Knowledge of the drug development process. Thorough knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to GCP. Thorough knowledge of local and/or country’s regulation pertaining to clinical trials and monitoring. Location & Compensation Location: San Diego, CA. Hourly rate range: $42.02 – $57.51. Equal Opportunity & Inclusive Hiring 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. Notice of Non-discrimination Employment Equity Read USC's Clery Act Annual Security Report USC is a smoke-free environment Digital Accessibility #J-18808-Ljbffr Itlearn360