Clinical Research Operations Core

The National Institute of Allergy and Infectious Diseases (NIAID) is seeking a contractor to provide clinical research operations core services in support of its mission. The contractor will be responsible for conducting clinical trials, including project management, protocol development, and clinical operations. The contract will be an Indefinite Delivery Indefinite Quantity (IDIQ) type contract, and the contractor will be required to collaborate with companies under contract to NIAID that provide clinical site monitoring, regulatory support, safety oversight, and data management and analysis. The contract will support tasks in the following areas: Project Management and Protocol Development, Protocol Implementation and Clinical Operations, and Research Laboratory Analysis. • The contractor will be responsible for conducting clinical trials using qualified clinical staff with expertise in carrying out all aspects of interventional clinical trials. • The contractor will be required to collaborate with companies under contract to NIAID that provide clinical site monitoring, regulatory support, safety oversight, and data management and analysis. • The contract will support tasks in the following areas: Project Management and Protocol Development, Protocol Implementation and Clinical Operations, and Research Laboratory Analysis.