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 "Best Practices" at each site.

CMs define goals and progress, contribute innovative solutions to implementation of studies, and determine clinical needs of research projects. Other duties include developing productivity and data management tools and working with other groups to provide operational and strategic support. CMs independently conduct study site visits that include training and leading site personnel (PIs, study coordinators, physicians) in protocol procedures and compliance, implementation, and administration of neuropsychological tests. CMs also facilitate and attend meetings as well as participate in conference calls with trial Project Directors and other ADCS team members as required.

MINIMUM QUALIFICATIONS

• Seven (7) years of related experience, education/training, OR a Bachelor’s degree in related area plus three (3) years of related experience/training

• Proven self-discipline and sound, independent judgment completing complex assignments. Monitors must be able to work independently as well as a team to ensure the success of our trials. ADCS monitors function as ambassadors to ADCS sites and therefore must possess the ability to make independent judgments that will not endanger the integrity of the trial, trial data, or most importantly, participant safety.

• Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents. As stated previously, monitors must be current with CITI training, GCP, and have a thorough knowledge of each of the trial protocols that they will be monitoring. Knowledge of FDA regulations and regulatory compliance is also critical as it pertains to each study.

• Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology. ADCS monitors are expected to contribute to the design of the monitoring plan for each trial, and therefore, must have experience and knowledge of trial and research designs, particularly those related to the monitoring of the trial/study.

• Proficiency in public speaking, and writing. ADCS monitors must have exceptional communication skills since they work very closely with site personnel, which includes study coordinators, nurses, doctors, administrators, etc. They are also frequently asked to present at Investigator Meetings, which requires speaking to diverse and large audiences. Monitors must also have excellent writing skills since they are required to complete and submit monitoring reports related to each of their site visits. This documentation is essential to the conduct of each trial.

PREFERRED QUALIFICATIONS

• Clinical Trials certification preferred.
• Conflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest. Monitors should be aware of COI in regards to ADCS disclosure reporting to ensure that sites are not approved to begin screening participants until COI has been reviewed and no conflicts have been determined/and or have been resolved.

SPECIAL CONDITIONS

• Employment is subject to a criminal background check.
• Must be willing to travel potentially up to 80% of the time and work onsite at the ADCS when not traveling.