Brown University's Institutional Review Board (IRB) is charged with ensuring that all aspects of human subjects research comply with applicable laws, regulations and institutional policies. Under the direction of the Associate Director, the IRB Manager is responsible for applying policies, procedures and regulations related to the conduct of human research projects at Brown University to a portfolio of protocol submissions of varying risk levels.
Management and review of IRB protocol submissions 75 %
The IRB Manager will work with a high degree of independence to:
- Evaluate incoming studies for prospective risk, including identifying required revisions to protocols;
- Assign a review type based on risk and coordinate appropriate consultations as needed;
- Work with investigators to ensure that requested modifications to the protocol or to the informed consent are completed;
- Assign reviewers and secure additional information as needed for IRB members' review;
- Consolidate reviewer comments into a clear and concise communication to investigators, and evaluate actions taken by investigators in response to IRB reviewers comments;
- Attend all IRB meetings, serving as key advisor on matters pertaining to protocol review;
- Authorize release of IRB approvals and associated contract and grant funds supporting research;
- Identify areas for interpretation by the Associate Director/Director/legal counsel that may arise after review of specific studies, and secure timely consultation for the review of these studies;
- Recommend and assist with recruitment of IRB members for Institutional Official approval.
Outreach, education and advising investigators and research staff regarding IRB protocol preparation 15%
The IRB Manager will provide support to the human research community to ensure quality IRB protocol submissions by:
- Providing in-person and phone consultation to investigators and their research teams regarding federal regulations, institutional policies and HRPP procedures to facilitate timely review and approval of protocol submissions;
- Providing guidance regarding risk categories for research, helping investigators appropriately identify which review process and procedures (e.g., non-human subjects research, undergraduate application, exempt, expedited or full Board review) to follow when they submit protocols for review;
- Develop educational materials for presentations to human subjects researchers at various levels of the organization (e.g., undergraduate students, graduate students, faculty investigators, etc.) and provide instruction in classrooms, departments, and in small and large group forums.
Development of IRB/HRPP Policies, Guidance and Standard Operating Procedures (SOPs) 10%
The IRB Manager will ensure that the Brown HRPP's processes and procedures are compliant with evolving regulations and sponsor requirements by:
- Assisting with development of HRPP policies, procedures and website content to provide clear and consistent education and information to our research community;
- Helping to identify any programmatic gaps and assisting with designing and drafting Brown HRPP SOPs to fill such gaps
1.) The IRB Manager is required to exercise extensive and independent professional judgment to evaluate studies for their potential risk to participants, through applying knowledge of federal, state and local regulations, policies, and guidelines. He/she is expected to maintain current regulatory knowledge to determine the most expeditious processing mechanism to be followed for each application, including submissions proposing to conduct clinical trials.
2) The IRB Manager is expected to apply his/her regulatory knowledge to independently develop appropriate training materials and administer outreach and education to Brown's research community.
3) The IRB Manager has the authority to advise all members of Brown's research community on various types of queries, including complex queries that are communicated via email or phone. Similarly, the IRB Manager has the authority to answer and address concerns of human subject participants that contact the Brown HRPP about a study.
4) The following decisions require input from the IRB Manager: rejection of a submitted protocol, suspension or termination of an active human research study, need for an emergency IRB meeting or report to an external agency, establishing IRB membership to ensure that the membership of the IRB appropriately reflects the needs of the Brown research community and its fields of research.
Education and Experience
Bachelor's degree or equivalent combination of education and experience.
- Five to seven years' experience as an IRB Coordinator, Manager or the equivalent in a Human Research Protection Program;
- Working knowledge of 45CFR Part 46 and FDA regulations; must demonstrate an in-depth understanding of operational requirements pertaining to the management and implementation of protocol review processes;
- Demonstrated depth and breadth of knowledge to advise and problem-solve on University-wide issues related to the conduct of human research studies;
- Demonstrated ability to write cogent, concise and detailed communications and policies/procedures. Exceptional oral and written communication skills required, particularly as it relates to conveying complex regulatory requirements and/or IRB feedback;
- Strong knowledge of grant and contract administration as well as conflicts of interest in research;
- Tact and diplomacy in working with Investigators and sponsors;
- Compassion, sensitivity and a high level of discretion when engaging with participants and in maintaining confidentiality.
Criminal background and educational checks
Recruiting Start Date:2019-06-17-07:00
Job Posting Title:Institutional Review Board Manager
Department:Office of Research Integrity
Time Type:Full time
Scheduled Weekly Hours:37.5
Please note that in order to be considered an applicant for any staff position at Brown University you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application.
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