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Washington University of St. Louis Expedited Review Specialist - Human Research Protection Office - 50607 in St. Louis, Missouri

Job Type/Schedule

This position is full-time and works approximately 40 hours per week.

Department Name/Job Location

This position is in the Human Research Protection Office. The position is located at the Mid Campus Center. This position is for the Medical School Campus.

Essential Functions

POSITION SUMMARY:

The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) regulations mandate that institutions receiving federal research funds maintain an Institutional Review Board (IRB) to review all human subject research proposals so as to “protect the rights and welfare of human subjects.” The Washington University (WU) IRB, Human Research Protection Office (HRPO), reviews and monitors all research involving human subjects conducted by WU faculty/staff and all research conducted at any WU affiliated institution.

This position is an IRB committee member designated to conduct and approve expedited review of biomedical and behavioral research involving human participants. Like review by the convened IRB, expedited review must fulfill all the requirements of review according to applicable HHS and FDA regulations.

PRIMARY DUTIES AND RESPONSIBILITIES:

  1. Review biomedical and behavioral research studies for compliance with Federal regulations and Institutional (WUSTL/HRPO) policies and procedures. Identify issues or concerns that must be addressed in order to approve the research under the expedited procedure. Research reviews will include new and continuing review of studies, modifications, etc.
  2. Provide justification for expedited classification or refer the submission to the full board committee if expedited classification is found not to be appropriate.
  3. Communicate with investigators (via telephone, myIRB and in person) to facilitate the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any. Contingencies (requests for changes or clarifications) should include standard statements from myIRB manual, regulatory guidance and education as applicable. Communications must be clear, concise, and grammatically correct.
  4. Maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research.
  5. Provide guidance to research coordinators and investigators regarding applications in preparation for submission to HRPO, via myIRB, SWAT on call and office hours.
  6. Consult with other experts as needed to conduct informed, qualitative review of biomedical and behavioral research involving human participants. Experts may include physician-scientists or other clinical professionals, HRPO colleagues and scientists in the social-behavioral-educational sciences, HRPO and Institutional colleagues in research administration.

OTHER RESPONSIBILITIES:

  1. Serve as a primary reviewer and voting member of a convened IRB.
  2. Serve as a resource for other IRB members.
  3. Perform educational presentations (formal and informal) to HRPO colleagues, to WU research community, and at national meetings of IRB professionals.
  4. Participate in special projects, development of guidance documents, and/or quality assurance/improvement assessments.
  5. Other duties as assigned.

Required Qualifications

  • Bachelor’s degree is required.
  • Must have working knowledge of the federal regulations governing research, including the new HIPAA regulations.

Preferred Qualifications

  • Master’s degree preferred.
  • Two to three years of experience in clinical research and/or IRB experience preferred.
  • Comprehension of and ability to problem solve within the framework of federal regulations, laws, and guidance pertaining to human subject protections, including 45CFR46, 21CFR50,56, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report, and the HRPO Policies and procedures.
  • General medical knowledge and familiarity with the scientific process and research design.
  • Comfortable making independent decisions within a designated framework.
  • Detail oriented, including auditing skills.
  • Ability to manage several projects at once.
  • Conceptual thinking and the ability to apply knowledge to a variety of situations.
  • Excellent communication skills, written and oral, including public speaking.
  • Cooperative and positive attitude.
  • Enjoys working independently and as part of a team.
  • Accepts and adapts to changes in office procedures or priorities.
  • Experience with Microsoft Office Professional software (Word, Access, Excel, Power-Point, Outlook).
  • Clinical research coordinator and/or human research regulatory coordinator experience.

Salary Range

The hiring range for this position is $51,293 - $66,685 annually.

Pre-Employment Screening

All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.

Benefits

This position is eligible for full-time benefits. Please click the following link to view a summary of benefits: https://wustl.box.com/s/8wkhs25yssf0775x9d6nd6vqa7obpth7.

Applicant Special Instructions

Successful applicant will be expected to obtain and maintain Certified IRB Professional certification upon meeting eligibility requirements.

EOE Statement

Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.

Job Title: Expedited Review Specialist - Human Research Protection Office - 50607

Job ID: 50607

Location: Medical School

Full/Part Time: Full-Time

Regular/Temporary: Regular

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