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:
Independently conducting visits to assigned study sites. During each visit, incumbent will review all case report forms (CRF) (either in electronic and/or paper form) at each assigned center, verify that requested corrections to forms have been made, and compare the CRF with source documentation, to ensure accuracy of data entry.
Review Regulatory Documents to ensure completeness and retrieve documents for the Trial Master File.
Responsible for reviewing and evaluating clinical interviews (such as Clinical Dementia Rating) and neuropsychological tests and ensure interviews are rated and tests are scored in a standardized manner. This involves reviewing interview and scoring materials, and contacting centers as necessary to review interview and rating procedures. Will oversee and provide guidance to the Project Coordinator in quality control activities within the Coordinating Center.
Perform audits and ensure all data necessary for analysis has been collected and shows to be accurate, giving special attention to primary outcome measures, as well as, safety measures.
Serve as primary contact for sites regarding questions about study conduct as well as medical safety in conjunction with the ATRI medical safety team.
For drug trials, as a matter of primary importance, accurately conduct completion of drug accountability.
Experience in AD research is preferred.
Up to 50% travel may be required at times.
Location:Â San Diego, CA
Salary is dependent on education and experience.
Minimum Education: Bachelor's degree, Combined experience/education as substitute for minimum educationMinimum Experience: 2 yearsMinimum 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 countryâs regulation pertaining to clinical trials and monitoring.
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