Division of Allergy, Immunology, and Transplantation
National Institutes of Health
Department of Health and Human Services
The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest Institutes of the National Institutes of Health (NIH), is seeking an exceptional and motivated leader to serve as a physician within the Clinical Research Operations Program (CROP) in the Division of Allergy, Immunology, and Transplantation (DAIT). DAIT supports basic and clinical research to improve our understanding of fundamental immunology and diseases such as asthma, food allergy, autoimmune diseases, and transplantation immunology to ultimately develop better diagnostic, treatment, and prevention strategies. DAIT’s extramural clinical research program supports approximately 100 ongoing, including 25 recruiting, clinical trials per year.
The physician will have a wide range of responsibilities relating to the oversight of data management of a major extramural clinical research program. Duties include the oversight of all aspects of clinical data management both within CROP and for our awardees. This includes oversight and coordination of clinical trial data management and process development, data quality processes, and systems development. The development and implementation of standard operating procedures and data and process flows in all areas of clinical data acquisition and management are significant areas of responsibility, as well as overseeing the division’s clinical trial research protocol review and safety monitoring committees.
D. or D.O.
Relevant training or board certification in one or more fields of clinical immunology
Candidates must have specialized experience in the following fields:
Management of clinical trial data, particularly for large, complex, multi-center studies
Oversight of clinical research organizations, including clinical trial data centers
Familiarity with clinical trial networks
Regulatory requirements for clinical trial research, particularly those relating to data collection and management, including 21 CFR Part 11 and ICH requirements
Quality processes and systems, particularly the development of clinical data and process flows and clinical trial quality management system software
Conduct and oversight of clinical trials, participant safety monitoring, and human research protections
Analytical abilities with respect to all aspects of clinical research
Effective within a team-based environment supporting clinical operations
Oral and written communication skills and the ability to present operational systems and issues to internal and external audiences
Candidates should also have familiarity with the following fields:
Relevant data standards, such as Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM), Clinical Data Interchange Standards Consortium (CDISC), Analysis Data Model (AdaM) and Good Clinical Practices (GCP)
Basic immunological mechanisms and their importance in immune-mediated diseases, including asthma and allergy, autoimmunity, and transplantation
Salary is dependent on experience and qualifications.
Visit www.USAJobs.gov and access the detailed vacancy announcement NIH-NIAID-DH-19-10361287 beginning December 5, 2018. Applications must be submitted online by 11:59 p.m. on December 14, 2018.
Visit NIAID Careers for more information about working in NIAID’s dynamic atmosphere.
HHS, NIH, and NIAID are equal opportunity employers.