CSP is recruiting for a Quality management specialist at one of their Clinical Trials Coordinating Centers. This position will be located at the VA Medical Center in Hines, Illinois (in the Chicagoland area).The Cooperative Studies Program (CSP) is a Veterans Health Administration (VHA) Office of Research & Development (ORD) supported national clinical investigation program that is comprised of a network of centers and investigators. The Program is responsible for the planning and conduct of large, multi-center trials in the Department of Veterans Affairs (VA).
Researchers within CSP have an opportunity to advance the health and care of Veterans through cooperative research studies that produce innovative and effective solutions to Veteran and national healthcare problems. Through collaborative efforts within VA and with other federal, international, university, and private industry partners, CSP accomplishments have included key research findings across a range of diseases and have helped to provide definitive evidence for clinical practice change.
The Quality management specialist serves as the subject matter expert for organizational quality, including regulatory compliance for accreditation, management of quality programs, and analysis and measurement of quality outcomes and performance measures. The incumbent also works cooperatively with staff at the Hines CSPCC, counterparts at the other CSP coordinating centers, and other program officials in VA Central Office.
MINIMUM REQUIREMENTS AND RESPONSIBILITIES:
Knowledge of quality assurance principles and methods to develop plans, policies, and procedures
Knowledge of research and development programs in a healthcare setting
Knowledge and experience in ISO principles, concepts, and technology to support ISO accreditation in a clinical research environment
Technical knowledge of health care and research regulations and accreditation for compliance with FDA, DEA, EPA, OSHA, and ICH standards
Ability to consult staff on corrective and preventive action and root cause analysis
Excellent interpersonal and written communication skills
Skilled in process mapping, process analysis and tools for management of quality improvement programs
3 years of experience in clinical research field preferred
A minimum of a master’s degree in Public Health, Regulatory, Science or Technology field.
Must be a US citizen as this is a federal government position.