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, and approximately 40 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. Recommends and implements policies and procedures based on UCSD, federal and state agencies, central and local IRBs, and FDA regulations and policies, as well as adherence to study-specific protocols relevant to compliance. Provides leadership over compliance matters and committees. Manages all issues related to relevant compliance area. Serves as a liaison between the organization, monitoring team, site PIs, Clinical Operations, Data Management, Administration, and other internal stakeholders as well as regulators.
Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Reviews and approves recommendations for Research Compliance and ensures compliance to protocols and regulations for Human Subjects research. Provides guidance to subordinates to achieve goals in accordance with established policies. Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall clinical trials timelines. Of greater consequence, erroneous decisions have the potential of putting patient safety at risk.
Bachelor's Degree in related area; or combination of equivalent experience and training.
A minimum of seven (7+) or more years of relevant experience.
Proven ability to employ leadership skills effectively across functional groups. Managerial experience and proven success in managing compliance review boards or committees.
Familiarization with IRB and FDA regulations related to clinical monitoring activities for clinical trials.
Skill in establishing relationships with relevant regulatory agencies. This includes local and central IRBs and FDA as needed.
Strong ability to communicate effectively across teams and to convey complex ideas so that they are easily understood by non-subject matter experts. Ability to motivate teams to ensure clinical trials timelines are met.
Ability to apply a complex array of issues, mental flexibility, and creativity related to compliance issues. Ability to identify "big picture" organizational needs in addition to thinking at a team-based level to apply solutions that will benefit the organization as a whole.
Ability to formulate policy recommendations. Ability to justify policy recommendations based on facts and best practices and create plans to implement them.
Master's Degree highly preferred.
Clinical Trials certification or equivalent experience.
Experience as a clinical monitor (CRA) for multi-site clinical trials, especially in Alzheimer's Disease and Dementia.
Previous experience as the Director of Clinical Monitoring, or as a Senior CRA supervising a team of CRAs highly preferred.
Employment is subject to a criminal background check.
Must be able to work outside of normal business hours, as necessary, including nights and weekends as needed to meet deadlines.
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