Overview
CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, bio-defense, and clinical research.
CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today!
We are seeking a Medical Officer to support the overall functions of the TB Clinical Research Branch, TRP, DAIDS at the National Institutes of Health (NIH).
Responsibilities
- Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of HIV/AIDS, 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 ensure 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.
- Conduct 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, providing 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 promote collaborations.
Qualifications
- M.D. or equivalent degree; active Medical license preferred
- Completed training in Internal Medicine or Pediatrics
- Training in Infectious Diseases or Pulmonary Medicine preferred
- Board Certification in Internal Medicine or Pediatrics, Infectious Diseases, or Pulmonary Medicine preferred
- Experience in in clinical trials, especially TB or other infectious diseases preferred
- Experience in TB clinical care or studies preferred
- The education, skills and relevant years of experience required for each support position are consistent with those identified as the minimum requirements for the labor categories specified in the contract