Senior IRB Analyst II, School of Medicine, Clinical Research
The Sr. IRB Analyst II provides administrative and regulatory support for the IRB staff, the IRB Chairs, the IRB Board members and the instititution's researchers. The Sr. Analyst II processes IRB submissions and serves as an alternate voting member on the IRB. The Sr. Analyst II is designated by the IRB Chair as an Expediter to sign off on IRB expedited reviews and can also sign off on expedited reviews conducted by junior IRB Analysts (who do not have Expediter privileges).The Senior Analyst II has additional responsibilities for making regulatory and administrative decisions in the absence of the IRB Director. The Senior Analyst II is responsible for training and oversight of new IRB staff, IRB Board members, and assists with training of IRB interns. This includes designing and conducting an ongoing series of educational presentations.
- Provides direct instructions, support, and regulatory guidance to researchers regarding IRB submissions and the INSPIR system. Provides in depth training and classes and educational programs for investigators and research teams. Provides education to IRB Interns, orients new Board members, IRB staff and develops educational materials for the CR Times (IRB newsletter)
- Performs regulatory analysis and administrative review of IRB submissions to ensure compliance with Federal research regulations (including new submissions, renewals, amendments, AEs, deviations). Maintains documentation in accordance with Federal regulations.
- Prepares all items other than initial reviews (amendments, continuing reviews, reportable events) for full Board review at IRB meetings; schedules meetings, pre-review of protocols, assigning protocols to reviewers, documenting review, processing modification memos, communicating with the Chair, providing regulatory advice, ensuring regulatory compliance, recording meeting minutes
- Performs administrative support to IRB office in the absence of the IRB Director, conducts training activities, supports the CR Times through editorial function, oversees HIPAA compliance
- Signs off on approval letters, conditional approvals, deferrals and other communications for IRB Analysts without expediter privileges
Work Experience: 3-5 Years
Education: Bachelor’s Degree required
Master’s Degree preferred
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.
Job Location Boston, Massachusetts, United States
Position Type Full-Time/Regular
Salary Grade Grade 75