Human Subject Protection Analyst

Updated: August 10, 2017
Job ID: 213096
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

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HJF is seeking a Human Subject Protection Analyst to support Compliance Operations, particularly the Institutional Review Board (IRB) operations and functions within the Human Research Protections Program (HRPP) of the Office of Research located at the Uniformed Services University of the Health Sciences (USU) in Bethesda, MD.  HJF provides scientific, technical and programmatic support services to USU. This position reports to the Director, Office of Research Compliance in administering all University activities related to human research protections, research policy and development, and educational activities. 

Responsibilities:

  1. As a member of the Compliance team, be able to conduct a pre-IRB review of submissions to an electronic system to ensure that all research and related activities outlined in the submission are in accordance with ethical guidelines and applicable Federal regulations, policies and procedures.
  2. Make recommendations on the appropriate type of review necessary to obtain compliance approval for the research and triage studies to the appropriate official or review body.
  3. Coordinate administrative activities before, during and after IRB meetings to facilitate the efficient review and approval of research protocols by the IRB.  
  4. Competent in oral and written communication methods including writing meeting minutes, memos and official letters that have appropriate grammar, spelling, and business correspondence formats.
  5. Participate in analyzing process and performance activity, trends, and outcomes related to research activity and compliance. 
  6. Participate in developing human subject protection and related policies for the research community in matters related to the ethical conduct of research involving human subjects and other relevant areas as may be required to meet federal, state, DoD regulations and University goals and  policies.
  7. Participate in developing educational activities for the research community and facilitate or conduct training sessions for Human Research Protections Program staff, IRB members, investigators, faculty and students in matters related to the ethical conduct of research involving human subjects and other relevant areas as may be required to meet federal, state, DoD regulations and University goals and  policies.
  8. Performs other functions as directed by the Director, Office of Research Compliance.
  9. Other duties as assigned.

Required Knowledge, Skills and Abilities:

  • Must possess a working knowledge of all DoD Instructions and Federal statutes and regulations pertaining to human subject’s research protections. 
  • Understanding of how policy is developed, approved, and implemented.
  • Understanding of organization and presentation of structured material to educate relevant target audiences in policy and process.
  • Possesses good interpersonal skills in order to express complex ideas, convey critical information, resolve conflict and foster teamwork and productive working relationships.
  • Possesses sufficient knowledge of computer use and applications including word processing.
  • Programs, spreadsheets and electronic submission systems and/or databases to log and track all information pertinent to human research protections.

Minimum Education/Training Requirements: Master’s degree in a scientific or related discipline or Certification as IRB Professional (CIP). 

Minimum Experience: 5 years-related experience in the area of human research protections or human research in a medical or scientific environment.

Supervisory Controls: Works under the supervision of the Director, Office of Research Compliance.  Work is reviewed in terms of being correct, complete, timely, and in conformance with all DoD and Federal regulations and USUHS policies and procedures.  Completed work is also reviewed critically outside the incumbent’s immediate office by the Chair and other members of the IRB, by the Vice President for Research, by the Institutional Office, and by other officials and personnel involved with human subjects research.

Physical Capabilities: Work is sedentary, although there is some standing or carrying of office supplies and materials, such as large binders and folders.  The work requires some walking but there are no special physical demands.

Work Environment: Work is performed in an office setting at the Uniformed Services University of the Health Sciences which involves everyday risks or discomforts and requires normal safety precautions.

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Director of Human Resources.

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