HRPP Compliance Assistant - part-time/17.5 hrs per week

Brigham Young University•Provo, UT
•$21 - $27

About The Position

The HRPP Compliance Assistant provides half-time, campus-wide research compliance support for Brigham Young University's Human Research Protection Program (HRPP), which oversees the Institutional Review Board (IRB) for Human Subjects. The position's effort is divided equally between IRB and HRPP responsibilities. Work includes screening human-subject research studies, assisting with education and outreach, maintaining records, and performing other duties as assigned by the HRPP Associate Director. The assistant supports the IRB's day-to-day operations in accordance with federal, state, and institutional regulations and policies. The position also helps the HRPP Associate Director with daily activities and supports training for IRB members, investigators, and campus researchers, with a focus on student training.

Requirements

  • Bachelor's degree and one year of experience in research administration, human-subjects research, regulatory compliance, healthcare, higher-education administration, or a related field; or an equivalent combination of education and experience.
  • Experience interpreting and applying policies, procedures, or regulatory requirements.
  • Experience managing multiple projects and deadlines in a fast-paced environment.
  • Strong written and verbal communication skills, including the ability to explain complex regulatory requirements clearly and professionally.
  • Strong attention to detail, analytical and critical-thinking skills, and organizational skills.
  • Ability to prepare meeting materials, correspondence, determinations, and other regulatory documents accurately.
  • Ability to provide customer service and regulatory guidance to investigators, study teams, students, and other stakeholders.
  • Strong interpersonal skills and ability to collaborate diplomatically with faculty, students, administrators, and staff.
  • Proficiency with Microsoft Office Suite and database or electronic workflow systems, and ability to learn new software.
  • Ability to exercise sound judgment, maintain confidentiality, and handle sensitive information appropriately.
  • Ability to work independently and contribute effectively as a team member.
  • Commitment to continuous learning and professional development in human research protections and research compliance.
  • Latter-day Saint members must hold and be worthy to hold a current temple recommend. Employees must abide by BYU's Honor Code and Dress & Grooming Standards and are expected to support and contribute to the university's academic and religious missions.

Nice To Haves

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

Responsibilities

  • Prescreen IRB 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, and maintain records and meeting attendance.
  • 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.
  • Assist committee members and investigators in using OneAegis software.
  • Assist with IRB member and new-member training.
  • Help create educational materials and prepare and present campus training as needed, with a focus on students.
  • Perform other related duties and participate in special projects as assigned.

Benefits

  • Employee assistance program available to the employee and all household members.
  • Access to the library.
  • Free on-campus parking.
  • Free UTA pass.
  • Discounts at the BYU Store and for many BYU events.
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