DESCRIPTION

The Alzheimer's Disease Cooperative Study (ADCS) was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego. The ADCS is a multi-center clinical trials consortium that provides an operational framework for large scale Alzheimer's disease research projects. The ADCS consists of 7 cores, 22 committees, 35 research sites that are members of the consortium/Steering Committee, and an additional 40 or more research sites located across the U.S. and Canada that participate in one or more trials coordinated by the ADCS. Annual funding for the ADCS ranges from $15-$25M. The ADCS provides expertise in developing Alzheimer's disease related protocols and is the coordinating center for multiple clinical trials of varying sizes and complexity under subcontracts funded by NIH and clinical trial agreements with industry partners.

Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies/procedures to apply FDA, federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and frequently with site staff and PIs outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately place research participant at undo risk and/or compromise the institution's assurance of regulatory compliance with the federal government.

Clinical Monitors (CMs) are an integral part of the ADCS clinical trials team. They frequently interface with sites and therefore represent the ADCS while monitoring sites, and are on the front lines in identifying and resolving questions or problems that sites may encounter. CMs work under the general supervision of the ADCS monitor manager. CMs are responsible for managing research trials for approximately 60 sites within the ADCS consortium conducting multiple clinical trials in Alzheimer's Disease (AD) at centers located throughout the United States and Canada.

CMs are responsible for adherence to FDA regulations, study protocols, SOPs, GCP and ALCOA guidelines, for all sites conducting ADCS studies. They are also responsible for ensuring the accuracy and integrity of data integrity at sites as well as appropriate documentation as outlined in FDA guidelines for clinical trials. CMs manage clinical research sites, identifying and introducing new monitoring procedures to optimize team performance, overseeing the execution of the Standard Operating Procedures, protocol implementation, and overseeing study close-out in order to maintain regulatory compliance and standardize