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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.
Incumbent will coordinate and oversee start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of clinical trial participants. Contributes intimate knowledge of protocols to create informational and recruitment materials. Acts as a liaison with other UCSD departments and agencies for the purpose of implementation of clinical trials. The Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase 1-3 research trials as well as lead, direct, and coordinate clinical operations efforts. Ensures compliance with state and federal regulatory guidelines and works with multiple sites across the ADCS network to ensure adherence to protocols, enrollment of trial participants, and adherence to timelines.
Works collaboratively with external stakeholders (sponsors, vendors, rater trainers, Site PIs, Project Directors, Site Coordinators), and internal stakeholders to ensure the quality of clinical research data. Provides direction and guidance to investigators. works with recruitment team to provide information to the general public concerning ongoing clinical trials. Assist PIs with proposals, progress reports, and manuscripts. Independently creates original documents and policies for assigned clinical trials. Ensures GCP and FDA regulations are followed.
MINIMUM QUALIFICATIONS
Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field and/or an equivalent combination of education and work experience.
Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.
Experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.
Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).
Proven experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.
Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.
Strong knowledge of investigational protocols especially with pediatric oncology protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).
Experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
Strong experience completing clinical trials case report forms via hard copy and online.
Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.
Working knowledge of medical and scientific terminology.
Proven ability to problem solve and resolve conflict.
Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility t
UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 8 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom - life is their laboratory. UC San Diego's rich academic portfolio includes six undergraduate colleges, five academic divisions and five graduate and professional schools. The university's award-winning scholars are experts at the forefront of their fields with an impressive track record for achieving scientific, medical and technological breakthroughs.
