The Department of Health and Human Services, National Institutes of Health has a continuing requirement for Clinical Research and Operations Management Support.

The mission of the National Institute of Dental and Craniofacial Research (NIDCR) is to support clinical research investigating the cause, incidence, prevalence, prevention and treatment of craniofacial, oral and dental diseases and disorders. This research, conducted through its extramural and intramural research programs, includes studies of diverse design, clinical settings, size, and complexity. NIDCR’s extramural program has a clinical research portfolio encompassing a broad range of clinical efforts. Studies span from small, short-term, pilot evaluations involving a single domestic site, to large, multi-year, multi-site clinical studies conducted both domestically and internationally. They include preventive and therapeutic interventional clinical trials as well as observational clinical studies. Currently, as listed on ClinicalTrials.gov, studies funded by NIDCR have recruited research participants to over 200 clinical trials and observational studies. The studies are in various stages, with several studies preparing to or actively recruiting, and others that are closed to enrollment but actively following enrolled subjects. Most clinical studies supported by NIDCR are performed at domestic sites, either at the NIH Clinical Center or at grantee and contractor institutions located within the United States. NIDCR also supports some international studies and multi-center studies with international clinical sites. The NIDCR has implemented specific policies and guidance documents to ensure studies involving human subjects, particularly if interventional, are conducted with appropriate oversight and rigor. It is critical that NIDCR supports clinical research that is safe and ethical with the intent to achieve valid results to gain knowledge and improve understanding of diseases that align with NIDCR’s mission. To assist with its clinical research oversight responsibilities, the NIDCR has relied on the Clinical Research Operations and Management Support (CROMS) contractor with specialized expertise. This support has allowed the Institute to have access to technical, regulatory, administrative and other resources not available internally. The clinical coordination efforts from the NIDCR Office of Clinical Trials Operations and Management (OCTOM) staff, in collaboration with the CROMS contractor, has led to a centralized and standardized approach to the management of its clinical research with support needs. It is anticipated that the need for clinical research management support will continue to grow given the NIH’s increased emphasis on oversight and Good Clinical Practice (GCP) standards to ensure the NIH supports only the highest quality clinical research.

• Task Area 1: Contract Continuation, Administration, Overall Project Management and Transition-Out Plan
• Task Area 2: Dedicated Onsite/Remote Contractor Support
• Task Area 3: Risk-based Clinical Site Monitoring
• Task Area 4: Data and Safety Monitoring Committee Support
• Task Area 5: Safety Surveillance Consultation
• Task Area 6: Regulatory Submission Support and FDA Interface Coordination
• Task Area 7: Statistical and Protocol Design Review and Consultation
• Task Area 8: General Maintenance and Update of NIDCR’s Information Management Systems