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Clinical Trial Safety Physician
4 months ago
Kelly Government Solutions is seeking an individual to work as a Clinical Trial Safety Physician at the National Institutes of Health. Position estimated to support a work arrangement that is mostly remote work with occasional on-site work at the NIH in Rockville, MD.
TASKS
(1) Review pharmacovigilance reporting strategies (e.g., safety monitoring plans), incoming safety data (e.g., adverse event reporting, safety committee’s reports), review of clinical study reports, investigator brochures, advisory committee recommendations, package inserts, and scientific literature.
(2) Work with staff on clinical protocol development, including providing input on study safety design (e.g., study objectives, subject safety, safety reporting), conducting reviews of clinical protocols and all supporting documents, and providing feedback to DMID staff and clinical investigators.
(3) Provide clinical expertise in the areas related to infectious diseases to Division of Microbiology and Infectious Diseases (DMID) staff and make recommendations about key clinical issues.
(4) When needed make recommendations and/or discuss clinical design and safety issues with representatives from various groups (e.g., DMID colleagues, industry representatives, contractors, grantees, and safety monitoring committee members) either by a written report or through discussion and/or presentation.
(5) Develop and maintain a proficiency in accessing and reviewing clinical study related information from databases used by DMID.
REQUIREMENTS
(1) Medical degree (MD) from an accredited university
(2) Minimum of ten (10) years of related medical experience
(3) Experience in evaluating adverse events as part of early phase clinical trials
(4) Demonstrate expertise developing and reviewing clinical trial protocols including input regarding study safety design