Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking a Medical Officer to support the National Institutes of Health (NIH) in Rockville, MD. This is an on-site position.
This is a Full-Time long term contract position which offers:
- Competitive compensation and comprehensive benefit package
- Optional health, vision, and dental plans
- Paid leave (min 120 hours) as well as 11 paid federal holidays and 401K plan.
- Access to NIH’s unparalleled resources and niche scientific initiatives.
- Learn more about what Kelly can do for you at https://government.kellyservices.us/
TASKS/SERVICES
Under this Task Order, the Contractor(s) shall provide services in support of the overall functions of the HIV Research Branch.
- Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of HIV/AIDS, its co-infections and/or related co-morbidities. This includes evaluating the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems that may impede a study.
- Advise program management of merits and deficiencies in proposed clinical studies.
- Provide subject matter expertise during protocol development leading to review at the Division level and ensures that the concerns raised during the review are addressed by the Protocol Development Team in a timely manner.
- Provide clinical expertise to assist in developing Investigational New Drug (IND) applications.
- Individuals providing this expertise will be named as reviewer of information relevant to the safety of the drug in question, on line 17 of the IND application (FDA Form 1571).
- Evaluate annual IND annual reports for medical safety and report findings to RAB.
- Provide medical expertise in protocol follow-up stages for subject safety and protection, reliability of study endpoint data and makes appropriate recommendations to DAIDS’ leadership to ensure trials are conducted according to protocol.
- Provide clinical and scientific information for preparing NIAID communications to the Food and Drug Administration (FDA), other government and nongovernmental agencies, pharmaceutical companies and Data Safety Monitoring Boards.
- Conduct site visits, when necessary, to obtain additional data and information for use by federal staff, in the consideration and evaluation of ongoing and future programs.
- Preview serious adverse event (SAE) reports, provides expert medical advice for potential impact of SAEs in ongoing research and participates in the preparation of reports submitted to the FDA.
REQUIREMENTS
- MD or equivalent degree with experience in clinical trials research.
- Minimum of two (2) years of related experience is required
