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 Position
The Quality Assurance Quality Integrity (QA/QI) Manager is a member of the Office of Research Integrity’s (ORI) QA/QI program team and is responsible for developing and maintaining a post-approval monitoring program for the unified human research protections program at Brown University and associated health systems. Through monitoring and auditing activities, the QA/QI Manager ensures that the PAM program is compliant with federal regulations, institutional policies, and AAHRPP standards, and helps ensure that the unified HRPP program at Brown University remains consistent with all applicable policies and processes. Additionally, the QA/QI Manager evaluates program operations and works in partnership with key program stakeholders to develop improvement initiatives across the research systems that lead to transparent, effective, and compliant operations.
The QA/QI Manager coordinates and conducts post-approval monitoring of human subject research activities for compliance with IRB approved protocols, generates visit reports for the IRB and other stakeholders, and works closely with the HRPP/IRB to compile, draft, and submit regulatory reports to agencies or sponsors, as needed, or to accrediting bodies.
With direction from OVPR and ORI leadership, HRPP group, the IRB, and other program stakeholders, the QA/QI Manager evaluates the human research program and its processes. This includes conducting independent reviews of research practices of approved protocols as well as the assessment and effectiveness of IRB committee procedures and business practices. The QA/QI Manager also assesses HRPP procedures, resources, and effectiveness by tracking, reviewing, and analyzing quantitative and qualitative program data, including protocol volume and review turn-around times.
The QA/QI Manager prepares reports and relevant programmatic data to ORI, HRPP, IRB, and OVPR leadership, and works closely with the Sr. Director ORI and the Director HRPP and the IRB Chairs to develop and implement programmatic changes. The QA/QI Manager serves as a liaison for the research community, the IRB, and the HRPP team. Though the QA QI Manager works in close partnership with the HRPP/IRB, it is independent of them to allow for objectivity and unbiased analysis and reporting.
Qualifications
Education and Experience
Required:
- Bachelor’s degree and 5+ years of related experience or equivalent combination of education and experience.
- Working knowledge of federal regulations protecting human subjects.
Preferred:
- Experience working in an HRPP office within an academic or clinical hospital/research setting.
- At least 3 years of related experience working in a research compliance setting, either in administration or conducting research.
- Experience with post-approval monitoring activities.
Competencies
- Thorough understanding of current federal and State regulations regarding human subjects research and ethical principles, Institutional policies, and integrated HRPP SOPs.
- Ability to practically apply federal and state regulations as well as institutional policies to research submissions under review.
- Ability to handle monitoring and auditing activities, including site visits, independently and competently.
- Ability to handle confidential documents and sensitive information.
- Ability to multitask and prioritize workloads.
- Excellent interpersonal, oral, and written communication skills.
- Ability to work independently and use judgment and discretion in potentially controversial matters.
- Ability to work with limited supervision and serve as a strong team member.
- Participation in continuing education and national and/or regional organizations devoted to promoting research ethics and the protection of human subjects.
- Proficiency in Huron electronic IRB submission system, Microsoft Office applications, Google platforms, Adobe and other commonly used software.
- Demonstrated ability to support a community of diverse perspectives and cultures in an inclusive environment.
Additional Information
Applicants are asked to include a resume.
We are unable to offer Visa Sponsorship for this position.
All offers of employment are contingent upon a criminal background check and education verification satisfactory to Brown University.
Benefits of Working at Brown:
Information on the Benefits of Working at Brown can be found here.
Recruiting Start Date:
2024-06-04
Job Posting Title:
Quality Assurance/Quality Improvement Manager (QA/QI 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.
What We Do
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 Public Health, School of Engineering, and the School of Professional Studies.
With its talented and motivated student body and accomplished faculty, Brown is a leading research university that maintains a particular commitment to exceptional undergraduate instruction. Brown’s vibrant, diverse community consists of about 6,200 undergraduates, 2,000 graduate students, 490 medical school students, more than 5,000 summer, visiting, and online students, and over 700 faculty members.
Brown students come from all 50 states and more than 115 countries. Undergraduates pursue bachelor’s degrees in more than 70 concentrations, ranging from Egyptology to cognitive neuroscience. Anything’s possible at Brown—the university’s commitment to undergraduate freedom means students must take responsibility as architects of their courses of study.
Brown University has 51 doctoral programs and 28 master’s programs. The broad scope of options vary from interdisciplinary opportunities in molecular pharmacology and physiology to a master’s program in acting and directing through the Brown/Trinity Repertory Consortium.
Around the world, nearly 90,000 Brown alumni are - in the words of Brown’s charter - leading lives of “usefulness and reputation” in every imaginable field of endeavor. Through events around the globe, reunions on campus, career resources, a host of online connections, and other services, the Brown Alumni Association fosters and supports a vibrant alumni community, wherever its members may be
