Job opening ID
Roles and responsibilities
Must be a US Citizen
Long term ongoing contract position
W2 with full benefits
Some travel may be required
National Institute of Allergy and Infectious Diseases
5601 Fishers Lane
Bethesda, MD 20892
•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.
•Work products and documents related to participating in the review, planning and implementation of clinical trials for the treatment and/or prevention of HIV/AIDS.
•Work products and documents related to providing subject matter expertise Provide clinical expertise.
•Work products and documents related to evaluating annual IND annual reports. Provide clinical and scientific information for preparing NIAID communications.
•Work products and documents related to conducting site visits. Preview serious adverse event (SAE) reports.
•Work products and documents related to attending and participating in national/international scientific meetings/conferences.
•Medical degree from an accredited university. Experience in evaluating adverse events
•Seven (7) years of experience in medicine or related field. Experience in the development of clinical trial protocols. Demonstrates experience in performing medical research.
•Experience in the clinical care of infectious diseases and experience in the conduct of clinical trials in HIV/AIDS or related infectious diseases.
•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
Number of positions