IRB Analyst Health Sciences Research

The Vice President for Research Institutional Review Board at the University of Virginia seeks an IRB Analyst for Health Sciences Research. IRB Analysts within the UVA Human Research Protection Program (HRPP) provide a high level of technical and administrative analysis in the processing of research activities involving human subjects. They serve as a liaison between the IRB and UVA research community and assist the IRB Chair and IRB Board members in ensuring that the rights and welfare of human subjects are protected throughout their participation in research projects. IRB Analysts conduct research application prereviews and other administrative support for the Institutional Review Board (IRB) for Health Sciences Research (IRB-HSR).

The IRB Analyst takes a proactive role in defining, evaluating, and conducting education and training programs related to IRB procedures and in accordance with ethical standards outlined by federal and state regulations and the policies of the University of Virginia.The Institutional Review Board (IRB) Analyst will report to the Director of the UVA Institutional Review Board for Health Sciences Research (UVA IRB-HSR) and work in collaboration with IRB-HSR Analysts and the IRB-HSR Chair. Remote work will be considered for this position.

Responsibilities:

• Advise investigators in preparing research applications and related documents for submission to the IRB. Ensure sensitive and confidential issues are concisely and properly communicated, negotiated, resolved, and documented.
  
• Perform preliminary administrative review of complex human subject research applications, including modifications, reportable events, and continuing progress reports and identify problems and issues in the submission application.
  
• Review and maintain submissions according to IRB administrative guidance and pertinent deadlines.
  
• Analyze all submissions for completeness, accuracy, ethical and regulatory compliance.
  
• Provide regulatory guidance to IRB members related to human subject research to ensure research is reviewed in compliance with institutional policies, as well as state and federal regulations pertaining to research including GCP and HIPAA.
  
• Prepare board meeting materials and attend board meetings to compose summaries of the board's deliberations for dissemination to investigators, which highlight board concerns, decisions, and the need for follow-up activity.
  
• Responsible for accurate data entry and frequent update of the database and general maintenance of the electronic records of all protocol review activities.
  
• Communicate professionally and efficiently with all levels of the UVA research community.
  
• Assist with refinement and update of IRB procedures for research review activities to ensure acceptability with changing federal regulations and University policies and disseminate information to investigators and staff.
  
• Provide education during educational venues.
  
• Provide back-up support for other IRB-HSR staff as needed.
  
• Obtain and maintain IRB Professional (CIP) certification when qualified.
  
• In addition to the above job responsibilities, other duties may be assigned.
  

Salary Information: Full-time position with an anticipated range of $46,000 - $60,000, commensurate with education and experience, includes UVA benefits.

Minimum Qualifications:

• Education: Bachelor's degree
  
• Experience: At least two years of relevant experience.
  

Preferred Qualifications:

• Knowledge of the Common Rule (45 CFR 46), FDA regulations, ICH Good Clinical Practice Guidelines, and other relevant requirements and guidelines related to the ethical study of human subject research
  
• Highly organized at tracking and prioritizing work
  
• Outstanding attention to detail
  
• Ability to write and speak in concise, accurate, and intelligible manner
  
• Ability to work independently with minimal supervision
  
• Analytical and problem-solving skills
  
• Diplomatic and professional interpersonal skills
  
• Ability to work well as part of a team in conditions of high volumes and rigid deadlines
  

Application Instructions: Please apply through Workday and complete an application online. Include the following documents:

• CV/resume
  
• Cover letter
  

All documents can be loaded into the resume submission field, multiple documents can be submitted into this one field. Internal applicants must apply through their UVA Workday profile. Incomplete applications will not be considered.

For questions about the application process, please contact J essica Speth, Academic Recruiter, at js9rk@virginia.edu.

Before a formal offer of employment is extended, the selected candidate will undergo a background check per university policy.

Physical Demands
This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings, and programs.

COVID Vaccination Requirement and Guidelines

Please visitthe UVA COVID-19 Job Requirements and Guidelines webpageprior to applying for current information regarding vaccination requirementsandguidelines for employment at UVA.

The University of Virginia, i ncluding the UVA Health System which represents the UVA Medical Center, Schools of Medicine and Nursing, UVA Physician’s Group and the Claude Moore Health Sciences Library, are fundamentally committed to the diversity of our faculty and staff. We believe diversity is excellence expressing itself through every person's perspectives and lived experiences. We are equal opportunity and affirmative action employers. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender identity or expression, marital status, national or ethnic origin, political affiliation, race, religion, sex (including pregnancy), sexual orientation, veteran status, and family medical or genetic information.