Director, Clinical Monitoring
Extended Deadline: Tue 9/8/2020
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.
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.
UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html