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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.
The Clinical Monitor Manager will provide leadership and direction for the ADCS Clinical Monitoring group (CRAs), which monitors multiple Alzheimer's Disease research trials in various phases, at over 60 sites throughout the United States and Canada. The incumbent will supervise a group of on-site and East Coast (remote) clinical monitors in monitoring activities for multi-site clinical trials to ensure compliance with study protocols, HIPAA, internal SOPs, and GCP/ICH. Incumbent will provide effective leadership and close guidance in leading the development, execution, and governance of clinical monitoring standards, protocols, and tailor monitoring plans to each trials specific needs.
In addition, the Clinical Monitor Manager will be responsible for making important original contributions pertaining to the clinical monitoring activities including strategically designating monitoring assignments to make most efficient use of the onsite and East Coast monitoring staff, setting priorities, goals, and objectives for the monitoring group, and developing strategies to meet goals, set expectations for individual monitors and manage performance accordingly.
The Clinical Monitor Manager will be accountable for deliverables and meeting timelines; collaborate effectively with other ADCS functional groups to carry out studies in various stages of development, maintenance, and closeout; facilitate various project meetings and conference calls and contribute original ideas. Will also be responsible for evaluating business needs, analyzing monitoring staff resources in conjunction with the Chief of Staff/Director of Administration, prioritizing workload, allocating resources to ensure appropriate assignment and fair distribution of workload, and for developing innovative solutions to improve monitoring processes.
The Clinical Monitor Manager will use advanced research compliance concepts to interpret highly complex and broad regulations, policies and guidelines. Regularly works on highly complex research compliance issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria to anticipate and identify problems and develop and implement the appropriate response and/or action. Serves as a technical expert and advisor to department head.
A Bachelor's Degree in related area; and/or equivalent experience/training required.
Must possess at least five (5) years of experience in clinical research monitoring; or a combination of at least five (5) years of monitoring and related clinical research experience and experience in supervising and managing others with ability to set and meet goals, motivate others, and hold individuals accountable for deliverables is required.
Advanced theoretical knowledge and experience of the clinical research methods, protocol design, and ability to identify necessary resources and procedures to carry out successful implementation of the clinical study.
Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents. Knowledge of FDA regulations, Good Clinical Practice Guidelines, and Standard Operating Procedures.
Strong knowledge and experience working with ICH, GCP, NIH, state and federal guidelines with ability to identify compliance issues.
Proven experience in clinical research trials and clinical trial protocol development. Knowledge of clinical trials components including stati
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