Clinical Trial Medical Monitor; Infectious Diseases Job Rockville Maryland USA,Doctor/Physician

Position: Clinical Trial Medical Monitor (Infectious Diseases)

Kelly Government Solutions is seeking a physician to work as a Clinical Trial Medical Monitor to support a portfolio of Phase I and II infectious disease clinical trials (vaccines, therapeutics, monoclonal antibodies, antifungals, etc.) at the National Institute of Allergy and Infectious Diseases (NIAID). Position estimated to support a hybrid work arrangement that is a mix of on-site and remote work at the NIH/NIAID in Rockville, MD.

Tasks

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.

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.

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.

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.

Develop and maintain a proficiency in accessing and reviewing clinical study related information from databases used by DMID.

Requirements

Medical degree (MD) from an accredited university

Minimum of ten (10) years of related medical and clinical research experience that includes leading safety oversight and risk management efforts for infectious disease clinical trials

Experience in evaluating adverse events as part of Phase I and II clinical trials

Demonstrate expertise developing and reviewing clinical trial protocols including input regarding study safety design

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