Senior IRB ANALYST II,MED School of Medicine, Clinical Research
Senior IRB ANALYST II,MED School of Medicine, Clinical ResearchTracking Code4016 Job Description
The Sr. IRB Analyst provides administrative and regulatory support for the IRB staff, the IRB Chairs, the IRB Board members and the institution’s researchers. The Sr. IRB Analyst processes IRB submissions, serves as an alternate voting member on the IRB. The Sr. Analyst is designated by the IRB Chair as an Expediter to sign off on IRB expedited reviews. The IRB Chairs and Board members rely heavily on the regulatory knowledge and expertise of the Senior IRB Analysts to guide their reviews and decisions.
Other duties include;
- Provides direct instructions, support, and regulatory guidance to researchers regarding IRB submissions and the INSPIR system.
- Provides support and assistance to investigators for individual IRB protocols, answering their questions and advising them about the Federal regulations and institutional policies.
- Performs regulatory analysis and administrative review of IRB submissions to ensure compliance with Federal research regulations and institutional policies (Including new submissions, renewals, amendments, AEs, deviations).
- Maintains documentation in accordance with Federal regulations and institutional policies.
- The Senior IRB Analyst can, at the direction of the Board Chair, independently review and approve Expedited and Exempt protocols and submissions (including new protocols, Progress Reports, Amendments, Deviations, AEs and Exceptions.)
- Prepares protocols for full Board review at IRB meetings and assists junior staff with full board meeting preparation; scheduling of 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.
- Must have a Bachelor’s Degree and 3 or more years of direct IRB experience. A Master’s Degree is preferred.
- Certified IRB Professional (CIP) certification will be required within 1 year of becoming eligible.
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 StatesPosition TypeFull-Time/Regular