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

Brigham Young University • Provo, UT

21h • Onsite

About The Position

This is a 1/2-time position that provides research campus-wide compliance support for the Human Research Protection Program (HRPP) which oversees the Institutional Review Board for Human Subjects (IRB). General responsibilities include screening human subject research studies, education outreach assistant, record keeping and other responsibilities as determined by the HRPP Associate Director; effort divided 50% to IRB and 50% to HRPP.

Requirements

• Bachelor's degree and one (1) 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, with the ability to communicate complex regulatory requirements clearly and professionally.
• A strong attention to detail.
• Strong analytical and critical thinking skills, including the ability to interpret policies, regulations, and guidance documents.
• Excellent organizational skills with demonstrated attention to detail and the ability to manage multiple competing priorities and deadlines.
• Ability to prepare meeting materials, correspondence, determinations, and other regulatory documents with a high degree of accuracy.
• Ability to provide exceptional customer service and regulatory guidance to investigators, study teams, students, and other stakeholders.
• Strong interpersonal skills and the ability to work collaboratively and diplomatically with faculty, students, administrators, and staff.
• Proficiency with Microsoft Office Suite and database or electronic workflow systems; ability to learn and effectively use new software applications.
• Ability to exercise sound judgment, maintain confidentiality, and handle sensitive information appropriately.
• Ability to work independently while contributing effectively as a member of a team.
• Commitment to continuous learning and professional development in human research protections and research compliance.
• Members of The Church of Jesus Christ of Latter-day Saints must hold and be worthy to hold a current temple recommend.

Nice To Haves

• One (1) 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

• Supports the day-to-day functions of the IRB in accordance with federal, state, and institutional regulations and policies.
• Prescreens submission packets (completeness and training credentials,)
• Screen for and learn to make determinations for exempt protocols
• Coordinate revision of applications and amendments
• Identify potential problems and issues and advise the IRB administrator.
• Assist with minutes as needed , transcribe recordings, maintain record-keeping and attendance at meetings.
• Assist the HRPP Associate Director in daily activities
• Takes the initiative in collecting 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 IRB member and new member training
• Assist in the creation of educational materials
• Prepare and present training across campus as needed with a focus on student training

Benefits

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

What This Job Offers

• Job Type: Part-time
• Career Level: Entry Level