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Brigham Young University

Private religious university in Provo, UT

HRPP Compliance Assistant

Regulatory Compliance & EthicsPosted on Nov 9
Part-timeProvo, UT, USA$20.75 - $27In-person

About the Job

Requirements

  • A firm commitment to the mission of BYU is required.
  • A bachelor's degree and one year of experience in research administration, human subjects research, regulatory compliance, healthcare, higher education administration, or a related field are required, or an equivalent combination of education and experience.
  • Experience interpreting and applying policies, procedures, or regulatory requirements is required.
  • Experience managing multiple projects and deadlines in a fast-paced environment is required.
  • Strong written and verbal communication skills, including the ability to communicate complex regulatory requirements clearly and professionally, are required.
  • Strong attention to detail is required.
  • Strong analytical and critical thinking skills, including the ability to interpret policies, regulations, and guidance documents, are required.
  • Organizational skills and the ability to manage multiple competing priorities and deadlines are required.
  • The ability to prepare meeting materials, correspondence, determinations, and other regulatory documents accurately is required.
  • The ability to provide customer service and regulatory guidance to investigators, study teams, students, and other stakeholders is required.
  • Interpersonal skills and the ability to work collaboratively and diplomatically with faculty, students, administrators, and staff are required.
  • Proficiency with Microsoft Office Suite and database or electronic workflow systems, and the ability to learn and effectively use new software applications, are required.
  • The ability to exercise sound judgment, maintain confidentiality, and handle sensitive information appropriately is required.
  • The ability to work independently while contributing effectively as a member of a team is required.
  • A commitment to continuous learning and professional development in human research protections and research compliance is required.

Responsibilities

  • Support the day-to-day functions of the Institutional Review Board (IRB) in accordance with federal, state, and institutional regulations and policies.
  • Prescreen submission packets for completeness and training credentials.
  • Screen protocols and learn to make determinations for exempt protocols.
  • Coordinate revisions to applications and amendments.
  • Identify potential problems and issues and advise the IRB administrator.
  • Assist with meeting minutes as needed, transcribe recordings, maintain records, and attend meetings.
  • Assist the HRPP Associate Director with daily activities.
  • Collect technical information from a wide variety of sources.
  • Maintain the confidentiality of information and records with tact and discretion.
  • Perform other related duties and participate in special projects as assigned.
  • Assist committee members in using OneAegis software.
  • Assist investigators in using OneAegis software.
  • Assist with training IRB members and new members.
  • Assist in creating educational materials.
  • Prepare and present training across campus as needed, with a focus on student training.

Desired Qualifications

  • One year of experience supporting an Institutional Review Board (IRB) or Human Research Protection Program (HRPP) is preferred.
  • Knowledge of federal regulations and ethical principles governing human subjects research, including the Common Rule (45 CFR 46), FDA regulations, and HIPAA privacy requirements, is preferred.
  • Experience using electronic IRB management systems, preferably OneAegis, is preferred.
  • Completion of CITI Human Subjects Research or IRB Administration training is preferred.
  • Experience working in a higher education, healthcare, or research environment is preferred.

About the Company

Brigham Young University

Private religious university in Provo, UT

Brigham Young University is a private religious university in Provo, Utah, providing undergraduate and graduate education guided by the mission of The Church of Jesus Christ of Latter-day Saints.

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