Job opening ID
Roles and responsibilities
Must be a US Citizen
Some travel may be required
Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking a Medical Officer to work onsite with the National Institutes of Health in Bethesda, MD.
This is a long-term contract position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com
•Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of HIV/AIDS, it co-infections and/or related comorbidities. 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 15 and 16 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.
•Conducts site visits, 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.
•Attends and participates in national/international scientific meetings/conferences in order to stay abreast of current research findings and to interact with other investigators to promote collaborations.
•M.D. with experience in the clinical care of infectious diseases and experience in the con-duct of clinical trials in HIV/AIDS or related infectious diseases.
•Six (6) years of experience in medicine or related field.
•Experience in the development of clinical trial protocols.
•Demonstrates experience in performing medical research.
•Board certification is preferred.
•ECFMG certification required if medical degree is from outside the United States.
•Experience in medical review of adverse events associated with clinical trials needed to support Expedited Adverse Event reporting and safety management and implementation.
•Excellent oral and written communication skills
Number of positions