IRB Manager

Job Description:

About Brown:

Brown University is a leading research university distinct for its student-centered learning and deep sense of purpose. Our students, faculty and staff are driven by the idea that their work will have an impact in the world.

Brown University offers a flexible work/life balance; summer hours, winter break and a comprehensive Benefits package including time off, annual paid holidays; benefits offerings including health, dental, vision, tuition assistance, retirement, wellness, employee discounts and more.  To learn about Brown University’s benefits, visit the University Human Resources web page here for further information.

About the Department:

The Human Research Protection Program (HRPP) is committed to cultivating a culture a research conducted ethically and with transparency. Our mission is to safeguard and promote the health and welfare of human research participants by ensuring that their rights, safety, and well-being are protected; provide timely and high-quality education, review and monitor human research studies; and facilitate excellence in human research. We do this by holding ourselves to high ethical standards and maintaining an environment of encouragement, support, and inclusivity; evolving and adapting with the changes of federal regulations and research policy; and working in partnership with our research community.

About the Opportunity:

The Office of Research Integrity has two openings available and is seeking to hire at the IRB Analyst or IRB Manager level. Candidate applications, resumes and cover letters will be reviewed and matched to the appropriate role based on their skills, education, and experience.

The IRB Manager is responsible for the administration and implementation of the Human Research Protection Program (HRPP) and Institutional Review Board (IRB) policies and procedures related to the conduct of human subjects research studies at Brown University. The IRB Manager ensures that all human subjects research activities conducted at Brown University comply with federal regulations, state and local law, and institutional policies. The IRB Manager conducts non-committee reviews and works collaboratively and independently with faculty, staff, and students. This role supports IRB Committee meetings, is responsible for preparing meeting agendas and materials, taking minutes, and advising IRB members on applicable regulations, policies, and review criteria. The IRB Manager is also expected to develop and implement outreach and education activities related to all human subjects research processes within their job scope.

The IRB Analyst works with the IRB Managers and the Associate Director of the Human Research Protection Program (HRPP) to apply policies, procedures and regulations related to the conduct of human research at Brown University to submissions of varying risk levels. They will also be responsible for the day-to-day independent management of the continuing review process for applicable IRB protocols. The IRB Analyst is expected to support IRB Committee meetings and assist with the development and implementation of outreach and education activities related to all human subjects research processes within their job scope.

Responsibilities:

Management and review of Human Subjects Research Applications and Revision submissions     

• Evaluate incoming Human Subjects Research applications and revision submissions for prospective risk, including identifying problems, issues in the submissions, and coordinate appropriate consultations as needed.
• Oversee the human subjects research review processes and related training of IRB members. Serve as key advisor at committee meetings on matters pertaining to Full Board reviews, write committee meeting minutes related to Full Board reviews, and release approvals.
• Assign a review type based on risk and coordinate appropriate consultations as needed.
• Contact investigators in a timely manner and work with them to ensure that requested modifications to the application or other application material 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 reviewer comments.
• Attend all IRB meetings, serving as key advisor on matters pertaining to application review.
• Authorize release of IRB approvals and associated contract and grant funds supporting research.
• Identify areas for interpretation by the Associate Director/Senior Director/legal counsel that may arise during the review of specific studies, and secure timely consultation for the review of these studies.
• Recommend and assist with recruitment of IRB members.
• Ensure that data entered into electronic submission systems are accurate and complete and recorded in accordance with established internal SOPs and policies.
• Manage and review other submission types as necessary to assist other HRPP staff.

Outreach, education and advising investigators and research staff regarding IRB protocol preparation   

• Provide consultation to investigators and their research teams regarding federal and state regulations, institutional policies and HRPP procedures to facilitate timely review and approval of submissions.
• Provide guidance regarding research review categories and help investigators identify which review process and procedures to follow before application submission.
• Assist with development of HRPP policies, procedures and website content to deliver clear and consistent education and information to the research community.
• Independently design and present educational materials for presentations on relevant subject matter areas (i.e., human subjects research, good clinical practice, HIPAA, multi-site research, etc.) to the Brown community at various levels of the organization and provide instruction in classrooms, departments, and in small and large group forums.
• Inform research participants of their rights as a participant, as warranted. Field incoming calls from prospective or active research participants, answer questions, and make referrals to HRPP leadership as needed.
• Maintain working knowledge of all regulations pertaining to human subject research and be able to independently field questions from investigators and others regarding regulatory requirements.

Development of IRB/HRPP Policies, Guidance and Standard Operating Procedures (SOPs)        

• Assists with the development of HRPP policies, procedures and website content to provide clear and consistent education and information to our research community.
• Helps to identify any programmatic gaps, and assist with designing and drafting Brown HRPP SOPs to fill such gaps.

Qualifications:

IRB Analyst – Grade 9 Position

Education and Experience

Required:

• Bachelor’s degree and 3 years of related experience or equivalent combination of education and experience.
• Working knowledge of federal regulations protecting human subjects.

Preferred:

• Experience working in an academic setting
• At least 3 years of direct human subjects research protection/IRB regulatory experience reviewing and processing IRB submissions
• CIP certification or willingness/ability to obtain CIP certification within three years of hire
• Working knowledge of federal regulations protecting human subjects
• Must demonstrate an in-depth understanding of operational requirements pertaining to the management and implementation of protocol review processes
• Experience with electronic submission systems or willingness to learn

Job Competencies

• Demonstrated ability to work independently on detailed analysis of complex policies, regulations, statutes and guidelines related to human subject research, problem solve and follow through on assignments with minimal direction. 
• 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.
• Demonstrated ability to support a community of diverse perspectives and cultures in an inclusive environment.

IRB Manager – Grade 10 Position

Education and Experience

Required:

• Bachelor’s degree and 5+years of related experience or equivalent combination of education and experience
• In-depth understanding of applicable laws, regulations, and policies related to human subjects research, including FDA regulations.
• Experience working in an academic or clinical research setting.

Preferred:

• CIP certification or willingness/ability to obtain CIP certification within two years of hire
• Must demonstrate an in-depth understanding of operational requirements pertaining to the management and implementation of protocol review processes.
• Comfortable managing and performing work in an electronic system.

 Job Competencies

• 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.
• Demonstrated ability to work independently on detailed analysis of complex policies, regulations, statutes and guidelines related to human subject research, problem solve and follow through on assignments with minimal direction. 
• 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.
• Demonstrated ability to support a community of diverse perspectives and cultures in an inclusive environment

All applicants must submit a cover letter and resume.

All offers of employment are contingent upon a criminal background check and education verification satisfactory to Brown University.

Recruiting Start Date:

2024-02-09

Job Posting Title:

IRB Manager

Department:

Office of Research Integrity

Grade:

Grade 10

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

Scheduled Weekly Hours:

37.5

Position Work Location:

Remote Eligible

Submission Guidelines:

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.

Still Have Questions?

If you have any questions you may contact [email protected] .

EEO Statement:

Brown University is an E-Verify Employer.

As an EEO/AA employer , Brown University provides equal opportunity and prohibits discrimination, harassment and retaliation based upon a person’s race, color, religion, sex, age, national or ethnic origin, disability, veteran status, sexual orientation, gender identity, gender expression, or any other characteristic protected under applicable law, and caste, which is protected by our University policies.