Clinical Operations Unit
The COU provides direct day-to-day operational support, management, and oversight for the IDCRC clinical research agenda - the planning, implementation, milestones, timelines for vaccines, biologics, therapeutics, diagnostics including prognostic and predictive markers, and devices, especially Phase I-IV clinical trials. This requires close coordination with all the units, the newly selected VTEUs as the research implementation sites, NIAID staff, and NIAID-provided research support programs. The COU provides leadership on protocol development and implementation planning and is responsible for site selection, qualification, and management of protocol-specific sites (CRSs).