Job Description

Join to apply for the Clinical Research Associate role at University of Southern California . 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 The incumbent will provide oversight of the progress of clinical trials at study sites, ensuring they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. Responsibilities include but are not limited to: Conduct onsite and remote monitoring for assigned clinical sites, review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring activities. Ensure sites follow GCP, regulatory requirements, study protocol, and ATRI policies. Document deviations from standard procedures. Review study data, manage queries, review inclusion and exclusion criteria, and ensure participant safety and protocol compliance. Serve as the main contact for assigned clinical sites. Develop a thorough understanding of the study protocol and manuals. Collaborate with Lead Clinical Monitors/Leads to escalate site compliance issues. Participate in monitoring activities to meet study milestones. Utilize internal and study-specific software and tools. Assist in training new monitors on study-specific or onsite procedures. Participate in sponsor, internal, and regulatory audits. Assist with eTMF filing efforts. Experience in AD research is preferred. Up to 50% travel may be required. Location: San Diego, CA The hourly rate range for this position is $42.02 - $57.51. USC considers various factors when extending employment offers, including experience, education, skills, and organizational needs. USC is committed to fair employment practices, including consideration of applicants with criminal records, in compliance with applicable laws. Minimum Education and Experience Bachelor's degree or equivalent experience/education Minimum of 2 years monitoring clinical trials and understanding of medical terminology Knowledge Requirements Thorough knowledge of ICH guidelines, GCP, FDA regulations, and local/country-specific regulations pertaining to clinical trials. Additional Details Seniority level: Entry level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industry: Higher Education #J-18808-Ljbffr University of Southern California

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