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. This position reports directly to the Director of Clinical Monitoring.

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 incumbent 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 incumbent 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. The incumbent 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.

Uses 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.

MINIMUM QUALIFICATIONS

• Nine (9) years of related experience, education/training, OR a Bachelor's degree in related area plus five (5) years of related experience/training. Prior managerial experience is preferred.

• Relevant compliance certification, such as CITI training, GCP, HIPAA, required.

• Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments.

• Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents.

• Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology.

• Strong proficiency in public speaking, and writing.

• Minimum five (5) years experience in clinical research monitoring or a combination of at least five (5) years of monitoring and related clinical research experience as well as experience in supervising and managing others with demonstrated ability to set and meet goals, motivate others, and hold individuals accountable for deliverables is required.

• Proven ability to build productive relationships with people of all types of backgrounds, pers