Brown Universityâ™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.
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 membersâ™ 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 reviewing 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.
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.
The IRB Manager will ensure that Brown HRPPâ™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
Education and Experience
Bachelorâ™s degree or equivalent combination of education and experience.
Indicate the essential job competencies. Competencies are required knowledge, skills, and abilities necessary to perform the job successfully.
Five to seven yearsâ™ 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.
Educational and criminal background checks.
Frequently operates a computer and other office equipment such as a printer/copy machine.
Frequently moves about inside the office to access a printer, files, and other materials/equipment.
Frequently moves about campus to various locations for meetings.
Must possess a willingness and ability to support a diverse and inclusive environment.
Other duties as assigned.
Recruiting Start Date:
Job Posting Title:
Office of Research Integrity
Scheduled Weekly Hours:
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.
Brown University is committed to fostering a diverse and inclusive academic global community; as an EEO/AA employer, Brown considers applicants for employment without regard to, and does not discriminate on the basis of, gender, sex, sexual orientation, gender identity, national origin, age, race, protected veteran status, disability, or any other legally protected status.
Internal Number: REQ163186
About Brown University
Located in historic Providence, Rhode Island and founded in 1764, Brown University is the seventh-oldest college in the United States. Brown is an independent, coeducational Ivy League institution comprising undergraduate and graduate programs, plus the Alpert Medical School, School of Engineering, Executive Master of Healthcare Leadership and the IE Brown Executive MBA.