Job Description

Location: San Diego, CA 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. Duties Provide oversight to the progress of clinical trials at study sites, ensuring they are conducted, recorded, and reported in accordance with the protocol, SOPs, Good Clinical Practice (GCP), and applicable regulatory requirements. 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. Ensure sites follow GCP, regulatory requirements, study protocol, and ATRI policies. Document deviations from standard procedures with sites as needed. Review study data, issue and resolve queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs and ensure participant safety and protocol compliance. Act as main point of contact for assigned clinical sites. Develop a thorough understanding of the study protocol and manuals. Collaborate with Lead Clinical Monitor/Lead CRA to escalate 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. Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum education Minimum Experience: 2 years Minimum 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 Good Clinical Practices. Thorough knowledge of local and/or country’s regulations pertaining to clinical trials and monitoring. Job Details Seniority level: Entry level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Higher Education The hourly rate range for this position is $42.02 - $57.51. USC considers factors such as scope and responsibilities of the position, candidate experience, education/training, key skills, internal equity, and applicable laws when extending offers. USC will consider all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including fair chance ordinances. Please refer to the Background Screening Policy Appendix D for specifics. We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. External job postings listed for reference only: Assistant Clinical Research Coordinator - 135591; Research Assistant I - Immunobiology and Microbial Pathogenesis Laboratory, Dr. Hollern; Clinical Trials Associate/ Sr Clinical Trials Associate, Clinical Operations; Clinical Research Coordinator II - VANGUARD (NMCSD). We are an equal opportunity employer. Referrals increase your chances of interviewing at USC CERPP (Center for Enrollment Research, Policy and Practice) by 2x. Get notified about new Clinical Research Associate jobs in San Diego, CA. #J-18808-Ljbffr USC CERPP (Center for Enrollment Research, Policy and Practice)

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