University of Southern California Clinical Monitor in San Diego, California

Clinical MonitorApplyUSC Alzheimer's Therapeutic Research InstituteSan Diego, 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.

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 Operation Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements(s). Duties will include but are not limited to:

  • Independently conducting visits to assigned study sites. During each visit, incumbent will review enrollment numbers, upcoming screenings, recruitment/retention efforts, review rating assessments, and subject charts for eligibility confirmation.

  • Manage sites from site startup process to closeout.

  • Responsible for reviewing and evaluating clinical interviews (such as Clinical Dementia Rating and Preclinical Alzheimer Cognitive Composite) 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 ensures 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.

  • Serves 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.

  • Up to 50% travel may be required at times.

Salary is dependent on education and experience.

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 regulation pertaining to clinical trials and monitoring.

REQ20047315 Posted Date: 07/14/2017 - Thru date - 8/31/2017