Join the HJF Team!
The Henry Jackson Foundation (HJF) is seeking a Medical Research Analyst with an emphasis on the ethical and regulatory compliant design and implementation of research protocols to support Compliance and Quality Assurance 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/ Office of the Vice President for Research in administering all University activities related to human research protections, research policy and development, and educational activities.
- Interact professionally, competently, and at a peer to peer level, with researchers and review colleagues on the ethical and regulatory compliant design and implementation of research protocols
- Provide technical assistance, including 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
- Serve as a technical expert on a multidisciplinary team in the compliance review and evaluation of scientific projects to assess questions related to the mission and scope of the University and the Department of Defense (DoD)
- Manage an active research portfolio spanning a wide range of disciplines
- 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.
- Provide ongoing support for the analysis of potential risks and unanticipated problems, including physical, psychological, fiscal, monetary, , privacy, and confidentiality in the pre- and post-approval settings.
- Conduct site visits for compliance and quality as indicated
- Coordinate activities before, during, and after the compliance approval process to facilitate the implementation of quality and efficiency in the process
- Competent in oral and written communication methods, including minutes, memos, reports, and official letters that have appropriate grammar, spelling, and business correspondence formats.
- Participate in analyzing process and performance activity, trends, and outcomes related to research activity and compliance.
- 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.
- Participate in developing educational activities for the research community and facilitate or conduct training sessions for HRPPstaff, 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. Faculty appointment once time has been spent in the position, is a potential option.
- Performs other functions as directed by the Director, Office of Research Compliance.
- Other duties as assigned.
Required Knowledge, Skills and Abilities:
- Familiarity with the dynamics of health-related research - understanding not only the internal relationships of the organization with which the research is identified and conducted but also the practices and policies affecting health research efforts
- Recognizable accomplishment and career progression in a research activity related to health or biomedical or behavioral sciences
- Ability to work effectively and cooperatively with others - developing and maintaining good working relationships with Review Boards, representatives of collaborating academic institutions, the scientific community, public, and private organizations and agencies, and the general public, as well as supervisors, colleagues, and subordinates.
- Possesses good interpersonal skills in order to express complex ideas, convey critical information, resolve conflict and foster teamwork and productive working relationships. The ability to develop and maintain such relationships will be an important factor in the evaluation of the work.
- Working knowledge of IRB and HRPP responsibilities and operations
- Working knowledge of DoD Instructions and Federal statutes and regulations pertaining to human subject research protections
- Competence in time and resource management
- Understanding of how policy is developed, approved, and implemented.
- Understanding of how to organize and present structured material to educate relevant target audiences in policy and process.
- Possess sufficient knowledge of computer use and applications, including word processing to function effectively.
- Sufficient familiarity with computer programs, spreadsheets and electronic submission systems and databases to log and track all information pertinent to human research protections.
Minimum Education/Training Requirements:
Doctor of Medicine( MD)or Doctor of Osteopathy (DO) from a school in the United States or Canada approved by a recognized accrediting body in the year of the applicant's graduation; OR a Doctor of Medicine MD or equivalent degree from a foreign medical school that provided education and medical knowledge substantially equivalent to accredited schools in the United States. Comparability may be demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates (ECFMG) or a fifth pathway certificate for American students who completed premedical education in the United States and graduate education in a foreign country. Completion of a residency program with training in a specialized field of medicine in an institution accredited for training in the specialty by a recognized body of the American Medical Association.
Successful completion of all requirements for a Ph.D. (or equivalent doctoral degree), in an accredited college or university, including acceptance of the dissertation, in an academic field of the health or pertinent sciences (for example, biochemistry, molecular biology, physiology, etc.) allied to health or health related research. Successful completion of at least two years of post-doctoral training with supporting publications to demonstrate competence.
- Five years-related experience in the area of human research in a medical or scientific environment.
- Worked independently in planning, organizing, and conducting biomedical behavioral health, or health-related research
- Served effectively in research program administration in one of these fields; and acquired an understanding of the history, interests, internal dynamics, and relationships of organizations in which health research is conducted. This experience may be gained as a principal investigator of a grant or contract, or may otherwise be gained through active involvement in initiating research projects, developing protocols, conducting studies, documenting findings, interpreting results in a published report (journal), supervising staff, and managing the budget.
- Additional training in human research protection policy and practice such as Good Clinical Practice certification with a preference for a Certified IRB Professional (CIP) training. The GCP Certification available at https://gcp.nidatraining.org/ or at https://learningcenter.niaid.nih.gov/ is acceptable.
- Membership experience on an IRB, Data Monitoring Committee, or other similar experience activity is preferred.
The background of the applicant must show progressively responsible and successful experience (complexity of work in independent research and research program administration), to be eligible. Examples from different settings include, but are not limited to:
Serving as principal investigator or equivalent on a grant or contract which may include institutional grant support or foundation funds, but should have been obtained competitively; independent research, as evidenced by the development of a research project, and primary authorship of research publications in peer-reviewed journals; held position of Instructor, Assistant Professor or equivalent
Intramural Research at an Institute or Foundation:
Independent research, as evidenced by the development of research projects, and primary authorship of research publications in peer-reviewed journals; evidence of responsibility for significant aspects of laboratory/research unit (at least 3 years postdoctoral research); held position of Staff Fellow, Senior Staff Fellow, Research Associate or equivalent
Private Sector (Profit/Nonprofit):
Conceptualization and implementation of a research project, primary authorship on internal research reports or patents and/or publications in peer-reviewed journals; held position of Research Scientist or equivalent
Extramural Environment in a granting or funding organization
Review for completeness applications for research grants or contracts; study scientific literature in order to place the proposed research project in its relationship to the research being done in the subject matter area; respond to issues and concerns about specific applications or proposals pertaining to assigned areas.
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 USU 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 with desk risers provided to allow standing. The work requires some walking but there are no special physical demands.
Work Environment: Work is performed in an office setting at the USU 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.