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 Alzheimerâs Disease (AD) through innovative clinical trials.
Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).Â Duties will include but are not limited to:
Responsible for supporting the Medical Safety team, specifically the Clinical Monitors, in any assigned duties such as tracking in Excel, data cleaning and site correspondence.
Evaluates and reviews primary outcome data as outlined in the Monitoring Plan, in addition to closely monitoring safety measures. Ensures the reliability, validity & integrity of data through source document verification, remote monitor review of source documents with EDC, and generating queries as appropriate.
Participates in the execution of clinical trials. Monitors clinical trials in accordance with GCP and industry partnersâ expectations.Â
Interacts closely with Clinical Monitors and Quality Assurance to review Monitor Visit Reports per GCP guidelines, internal SOPs and Monitoring Plans prior to uploading reports to the eTMF
Initiates NTF's as applicable per review of Monitor Visit Reports and uploads Clinical Monitoring documents to the eTMF.Â
Provides training to Clinical Monitors as needed to help with the quality of monitoring visit reports per applicable guidelines.
Reviews and evaluates clinical test results and interviews and ensures that interviews and tests are rated, scored and standardized. Reviews and reports on the quality and integrity of clinical data.
Experience in AD research is preferred.
Location:Â San Diego, CA
Salary is dependent on education and experience.
Minimum Education: Bachelor's DegreeMinimum Experience: 0 - 6 monthsCombined experience/education as substitute for minimum education Minimum Field of Expertise: Familiarity with monitoring of clinical trials and medical terminology. Familiarity with the drug development process. Knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to Good Clinical Practices. Knowledge of local and/or national regulations pertaining to clinical trials and monitoring.
USC is the leading private research university in Los Angeles—a global center for arts, technology and international business. With more than 47,500 students, we are located primarily in Los Angeles but also in various US and global satellite locations. As the largest private employer in Los Angeles, responsible for $8 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 across a variety of academic and professional schools and administrative units. As a USC employee and member of the Trojan Family—the faculty, staff, students, and alumni who make USC a great place to work—you will enjoy excellent benefits, including a variety of well-being programs designed to help individuals achieve work-life balance.