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The Alzheimer's Disease Cooperative Study (ADCS) consists of 5 cores, 22 committees, 37 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 of more trials coordinated by the ADCS. Annual funding for the ADCS grant is approximately $10 million. 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.
Under supervision of the Alzheimer's Disease Cooperative Study (ADCS) Data Core Director, responsible for maintaining the integrity of the data collected by the numerous sites involved in ADCS clinical trials. Provides regular quality control audits on data from ongoing clinical trials. The Quality Assurance Research Associate will follow the data entry from case report forms received daily from off-site centers (30-40 per day), audit automatic validation reports, serve as liaison between site monitors and ADCS staff, auditing and problem resolution, address and resolve discrepancies, anomalies and missing record/data problems on a regular basis using a variety of tools including online electronic forms. The Quality Assurance Research Associate works with Clinical Monitors, Statisticians and other staff in completing daily corrections and assuring data is maintained in compliance with procedures defined in the specific protocol involved. The Quality Assurance Research Associate prepares reports using Access, SQL, and Excel to identify problems in data sets, such as missing entries and discrepancies, route and track CRF's and verify accuracy of data. Collaborates on the development and maintenance of data entry/error correction procedure manuals and processes. Participates in long-range planning for Data Management Group including developing and implementing new Quality Control procedures and process improvement strategies.
Theoretical knowledge of Public Health such as typically acquired by a Bachelor's degree or equivalent combination of educational and experience.
Experience in Alzheimer's disease clinical research trials. Knowledge of clinical trials components including statistics, study methodology, informed consent, eligibility, and adverse events. Demonstrated success and skill at researching, analyzing, and evaluating information for preparation of clinical research protocols.
Demonstrated knowledge of databases including design, development, management, and usage. Understanding of relational and object oriented databases, data and file types, and user interface design.
Skill to self-direct work, follow through on assignments, identify problems and recommend course of action for resolution. Demonstrated ability to organize and perform tasks independently, and prioritize tasks in a fast-paced environment.
Knowledge of scientific research, and the willingness and ability to learn new skills, research methods, and scientific principles.
Experience in presenting technical data in oral and written formats and producing reports using relational databases.
Basic knowledge and medical terminology associated with Alzheimer's and experience processing clinical case report form data.
Knowledge of PC computers, with experience using word processing, MS Office, Adobe Acrobat, SQL queries, and database systems. Knowledge of e-mail systems. Ability to learn new software programs as needed.
Experience using data tables and data dictionaries.
Must be willing to work occasional nights and weekends as necessary.
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