Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. We are seeking a Clinical Trial Safety & Protocol Development Physician (Medical Officer) to support the National Institutes of Health in Rockville, MD.
Role is estimated to support a hybrid work arrangement that includes a mix of remote and on-site work depending upon Institute needs.
This is a long-term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans
- Paid leave, paid federal holidays, and 401K plan.
- Access to NIH’s unparalleled resources and niche scientific initiatives
KEY TASKS
(1) Serve as a subject matter expert in the Respiratory Diseases Branch within the National Institute of Allergy and Infectious Diseases (NIAID) for clinical research studies and clinical trials on vaccines and therapeutics for viral and bacterial respiratory pathogens (including but not limited to Mycobacterium tuberculosis, Streptococcus, Bordetella pertussis, influenza, coronaviruses, and other emerging respiratory pathogens).
(2) Review clinical trial protocols and provide comments as for safety and operational issues with DMID sponsored protocols.
(3) Assess serious adverse events from clinical trials.
(4) Assess SUSAR notifications from outside companies; assess for impact to current studies.
(5) Perform periodic medical data review, including review laboratory values, adverse events, coding documentaries and data tables, listing and figures as needed.
(6) Review and provide recommendations on the design and safety of clinical trials that represent the Division in communications with the FDA, sponsors and academia partners while developing and implanting clinical trials.
(7) Provide medical/scientific expertise to project teams and advice on management of clinical trials.
(8) Review safety reports and represent DMID as safety expert on safety committees.
(9) Write policies and guidelines on safety related issues for Division sponsored studies.
KEY REQUIREMENTS
(1) Medical degree from an accredited university
(2) Minimum of ten (10) years of experience in medicine or a related field.
(3) Experience in the development of clinical trial protocols and related study materials for vaccine and therapeutics
(4) Experience evaluating adverse events of study products as part of early phase clinical trials.
(5) Experience conducting medical research.