Job Summary

The Institutional Review Board (IRB) Analyst has direct responsibility for assisting campus researchers in preparing human subject protocols, independently answering queries and providing authoritative information regarding regulations. The IRB Analyst carries out risk assessment and ethical pre-review of protocols, including analyzing content, independently determining adequacy of the application and level of review required, and developing extensive technical correspondence to researchers regarding necessary changes. The IRB Analyst is part of a team that provides a variety of functions, such as developing and delivering training, creating guidance, and screening off-campus recruitment requests.

Essential Functions

• Review and analyze human subject research protocol applications to identify potential risks to human subjects and the institution. Interpret extensive federal, state, and campus regulations regarding human subject research. Compose clear and concise written correspondence to researchers regarding deficiencies, inconsistencies, or ethical concerns.
• Analyze a variety of supplemental submissions including protocol revisions, adverse events, and continuing review of studies. Provide written feedback to researchers on how to address deficiencies in order to prepare submissions for approval.
• Represent UMass as the institutional representative for the federal Clinical Trials system that maintains information on studies available for the general public. Approve researcher’s submissions on behalf of the institution.
• Review off-campus researcher’s requests to recruit UMass students and personnel into research studies. Assess if appropriate precautions have been taken and IRB approval from the home institution is in place. Approve/decline requests as appropriate.
• Analyze and recommend actions relative to data use, data access, and data restrictions in human subject research.
• Attend IRB meetings and interpret committee deliberations that include complex scientific and regulatory language, concepts, and ethical concerns. Correspond with researchers regarding IRB deliberations and assess whether adequate risk mitigation factors have been built into the research prior to recommending approval.
• Enhance campus awareness of regulatory requirements and how to reduce risk when conducting human subject research. Develop relevant training materials and regularly deliver training sessions to faculty, staff, and students.
• Create written guidelines and tip-sheets for researchers. Document office procedures, work with office team to refresh campus standard operating procedures, and develop and update web-based materials.
• Organize and prepare IRB meeting agendas, assign appropriate IRB Committee primary and secondary reviewers, and select educational materials for the Committee that are relevant to current submissions. Assist in preparation of reports and correspondence related to IRB activities.
• Recommend updates to the electronic protocol management system and test updates once incorporated. Contribute to special projects in support of the Human Research Protection Office (HRPO) mission and other, regulatory tasks as necessary.
• Attend seminars, workshops, and professional conferences to remain current in the application of federal regulations to protocol review, especially in the atmosphere of new technologies and increasingly complex ethical questions.

About UMass Amherst

UMass Amherst, the Commonwealth's flagship campus, is a nationally ranked public research university offering a full range of undergraduate, graduate and professional degrees. The University sits on nearly 1,450-acres in the scenic Pioneer Valley of Western Massachusetts, and offers a rich cultural environment in a bucolic setting close to major urban centers. In addition, the University is part of the Five Colleges (including Amherst College, Hampshire College, Mount Holyoke College, and Smith College), which adds to the intellectual energy of the region.

About Research & Engagement

The UMass Amherst community engages more than 31,000 students, 1,400 faculty, and 5,000 staff in 11 schools and colleges with a wide variety of degree programs, research, and public service. More than 800 faculty lead sponsored research projects in many areas from basic to applied that are sponsored by federal, state, and private sources with expenditures of more than $240 million in 2023.

Minimum Qualifications (Knowledge, Skills, Abilities, Education, Experience, Certifications, Licensure)

• Bachelor’s degree, preferably in biomedical, social, or behavioral science field, plus two (2) years of related experience.
• Excellent verbal and written communication skills.
• Ability to deal effectively with high volume of protocols, rigid deadlines, and frequent changes.
• Demonstrated skills with variety of computer software programs (e.g., MS Word, Excel, PowerPoint).

Preferred Qualifications (Knowledge, Skills, Abilities, Education, Experience, Certifications, Licensure)

• Experience with human subject protocol review.
• Experience in the interpretation and application of regulations to written protocols.
• Experience in developing curriculum and presenting material (seminars, guest presentations, etc.) to inform students, researchers, and administrators on the ethics of human subject research.
• Certified IRB Professional (CIP) certification.

About University of Massachusetts Amherst

UMass Amherst, the Commonwealth's flagship campus, is a nationally ranked public research university offering a full range of undergraduate, graduate and professional degrees. The University sits on nearly 1,450-acres in the scenic Pioneer Valley of Western Massachusetts, and offers a rich cultural environment in a bucolic setting close to major urban centers. In addition, the University is part of the Five Colleges (including Amherst College, Hampshire College, Mount Holyoke College, and Smith College), which adds to the intellectual energy of the region.

Connections working at University of Massachusetts Amherst