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Regulatory Aspects of Human Subjects Research in the U.S. Army

Description
The Walter Reed Army Institute of Research (WRAIR) aims to conduct biomedical research that is responsive to U.S. Department of Defense and U.S. Army requirements and delivers lifesaving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter. This opportunity is located in Silver Spring, MD. For more information about WRAIR, please visit: https://www.wrair.army.mil/.

WRAIR has detachments for clinical, behavioral, and epidemiologic research in Asia, Africa, and Europe. WRAIR's Human Research Protection Program (HRPP) oversees approximately 350 active human subjects research protocols. Research protocols consisting of both biomedical and socio-behavioral, under many different reviewed categories such as: research not involving human subjects, exempt research with preexisting specimens/data, minimal risk research including epidemiologic investigations and survey research, clinical investigations exempt from U.S. Food and Drug Administration (FDA) regulations and those conducted under Investigational New Drug (IND) or Investigational Device applications. The participant will learn the specialized regulatory aspects of human subjects research in the U.S. Army, with a strong focus on the context in which international research is performed. Under the guidance of a mentor, the selected candidate will be taught and trained as a health scientist to complement their existing training and education by taking part in human subjects research design of studies that involve vaccines (first in human zika vaccine for example) and devices (new medical apps for personalized healthcare delivery).

Appointment Length
This appointment is a twelve month research appointment, with the possibility to be renewed for additional research periods. Appointments may be extended depending on funding availability, project assignment, program rules, and availability of the participant.

Participant Benefits
Participants will receive a stipend to be determined by WRAIR. Stipends are typically based on the participant’s academic standing, discipline, experience, and research facility location. Other benefits may include the following:
  • Health Insurance Supplement. Participants are eligible to purchase health insurance through ORISE.
  • Relocation Allowance
  • Training and Travel Allowance

Nature of Appointment
The participant will not enter into an employee/employer relationship with ORISE, ORAU, DOD, or any other office or agency. Instead, the participant will be affiliated with ORISE for the administration of the appointment through the ORISE appointment letter and Terms of Appointment.

Qualifications
Recent Masters in Regulatory Science, Public Health, Research Management, and/or Bioethics.

Preferred 5-7 years minimum work experience in health-care (example, RN, PA) or research related field with human subjects.