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Medical Officer
San Antonio, Texas, United States
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Job Summary

Occupation Physician
Specialty Academic/Faculty/Research
Degree Required MD/DO
Position Type Permanent/Full-Time
Work Environment Ambulatory Surgery Center (ASC) Academic/Training Program Hospital Clinic/Private Practice
Location Bethesda, Maryland, United States
Visa Sponsorship No

Job Description

Last Update: 5/31/16
Job Description: 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). 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. 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.
Job Requirements:

D. with experience in the clinical care of infectious diseases and experience in the conduct of clinical trials in HIV/AIDS or related infectious diseases.
Four (4) years of experience in medicine or related field.
Experience in the development of clinical trial protocols.
Demonstrates experience in performing medical research.
Experience in evaluating adverse events.
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.