IRB Analyst, School of Medicine
Tracking Code 8283/E2416
Performs regulatory analysis and administrative review IRB submissions by BU/BUMC investigators to ensure compliance with Federal research regulations and institutional policies. This includes review of submissions, renewals, amendments, adverse event reports, protocol deviations and exceptions. Maintains documentation of IRB review in accordance with Federal regulations and institutional policies. Conducts pre-review of expedited research and then sends to senior person for sign off- generates mod memos, investigator letters and approval letters at the direction of the Board review Board Chair. Responsible for preparing protocols for full board review at IRB meetings; scheduling of the meetings, pre-review of the protocols, assigning protocols to reviewers, documenting review, processing modification memos, communicating with Board Chairs and Panel members, providing regulatory advice and support, ensuring regulatory compliance, recording minutes of the IRB meetings. Review research protocols to ensure compliance with HIPAA research regulations. Provides direct instruction, assistance, support and regulatory guidance to researchers regarding IRB submissions and the IRB electronic system
Bachelors degree with 1-3 years of experience.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, 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