Medical Officer

Overview

We are seeking a Medical Officer
to support the National Institutes of Health’s (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member.

Accelerate your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security;

and HIV/AIDS programs.

Our employees enjoy a collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

• Participate in the review, planning, and implementation of clinical trials for the prevention and/or treatment of HIV, 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 reviewers 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 non‑governmental agencies, pharmaceutical companies, and Data Safety Monitoring Boards.
• Conducts 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, provide expert medical advice for potential impact of SAEs in ongoing research and participates in the preparation of reports submitted to the FDA.
• Performs other duties as assigned.

• M.D. degree required and 20+ years of experience in clinical trials research.
• Experience in the review, planning, and implementation of clinical trials.
• Experience with HIV, its co‑infections and/or related co‑morbidity events.
• Experience with IND applications. Specifically, FDA Form 1571.
• Strong communication skills.

Physical Requirements:

The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.

• Constantly required to perform sedentary work that primarily involves sitting/standing.
• Rarely required to perform light work that includes moving objects up to 20 pounds.
• Rarely required to push or pull less than 25 pounds.
• Rarely required to reach above shoulder level.
• Constantly required to use both hands.
• Occasionally required to stand or…