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 Medical Officer to work onsite with the National Institutes of Health in Rpckville, 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 co-morbidities; evaluate 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.
•Provide clinical expertise to assist in developing Investigational New Drug (IND) applications. Individuals providing this expertise will be named as reviewer of information rele-vant 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.
•Conduct 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.
•Attend and participate in national/international scientific meetings/conferences in order to stay abreast of current research findings and to interact with other investigators to pro-mote collaborations.
•Assess current literature and interacts with investigators to identify gaps and opportuni-ties in clinical research areas relevant to TCRB.
•M.D. with experience in the clinical care of infectious diseases and experience in Internal Medicine or Pediatrics
•Minimum of eight (8) years of experience in medicine or a related field.
•Board certification is preferred but not required
•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.
•Demonstrated expertise in performing medical research.
•Demonstrated expertise in developing clinical trial protocols.
•Demonstrated superior medical writing skills.
•Fellowship in Infectious Diseases – Board Certifications are good, but not essential
•Experience with research for infectious diseases – TB would be good, not essential
•Direct involvement with conducting a trial for TB diagnosis, treatment, or vaccines – publications good, but not essential
Number of positions