Clinical Research Operations Core

Background
The National Institute of Allergy and Infectious Diseases (NIAID) is seeking to implement clinical research operations to support its mission of addressing public health needs, including emergencies.
This solicitation aims to provide resources and services necessary for conducting clinical trials that will generate high-quality data to inform regulatory and policy decisions.

Work Details
The contractor will support a comprehensive range of activities for the implementation and conduct of clinical trials, which includes:
- Utilizing qualified clinical staff with expertise in all aspects of clinical trial operations and biospecimen management.
- Collaborating with NIAID grant recipients and contractors.
- Establishing domestic or international clinical trials in response to emerging infectious diseases.
- Managing project tasks across three main areas:
- Task Area A: Project Management and Protocol Development, including execution upon contract award.
- Task Area B: Protocol Implementation and Clinical Operations, with three task orders in Year 1 and six in subsequent years.
- Task Area C: Research Laboratory Analysis, executing two task orders each year starting in Year 2.
Additionally, the contractor must demonstrate relevant experience in designing, preparing, and conducting Phase 0-4 clinical trials targeting various infectious diseases, ensuring compliance with Good Clinical Practices (GCP) and FDA regulations.

Period of Performance
The anticipated period of performance for the IDIQ contract is ten years, with an ordering period of seven years starting on or about July 2026.

Place of Performance
The contract may involve both domestic and international locations for clinical trials.