Quality and Compliance 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 Opportunity

The Quality and Compliance (QC) Manager is a member of the Brown University Human Research Protection Program (HRPP) which supports all human subject research activities conducted at Brown University and associated Health Systems (Care New England and Brown University Health). The position works closely with HRPP colleagues, the Institutional Review Boards, and investigators to facilitate compliance and understanding of all applicable regulations, AAHRPP standards, and best practices (e.g., Good Clinical Practice (GCP), and promote the protection of research participants’ rights, safety, and well-being. The position is an integral part of the HRPP’s mission to strengthen human research protections and commitment to continuous improvement in research compliance.

This position supports the development and leading of a post-approval monitoring (PAM) program to ensure human subjects research is conducted in adherence with all regulatory requirements, institutional policies, and ethical guidelines. Monitoring and compliance activities include routine quality assessments, for-cause auditing, and risk-based monitoring strategies.  As a member of the HRPP, the Manager collaborates closely with HRPP team members to identify and address gaps in IRB oversight and the IRB’s responsibility for continuous monitoring. 

The Manager also assists the HRPP in their efforts to evaluate and improve the quality of their human research protections programs (HRPP) and strengthening its compliance with institutional and regulatory requirements for human subjects research. It evaluates the HRPP by conducting independent assessments of administrative processes, IRB committee procedures and business practices to improve overall program and committee functions. In addition, the Manager may provide guidance to the HRPP and University to use for programmatic improvements and development, such as SOPs, guidance, and educational offerings.

Additionally, the Manager may evaluate Research Integrity program operations as they relate to human subjects research activities, and works in close partnership with key program stakeholders, including the Export/COI, the Regulatory Advising Group, and the Research Training Program to develop improvement initiatives across the research systems that lead to transparent, effective, and compliant operations. 

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 activities with consistency and flexibility.
• Ability to conduct monitoring and auditing activities, including site visits, independently and competently.
• Ability to protect confidential documents and sensitive information, using judgment and discretion in sensitive matters.
• Ability to multitask and prioritize workloads.
• Excellent interpersonal, oral, and written communication skills.
• Ability to effectively evaluate needs and educate.
• Ability to work with limited supervision and serve as a strong team member.
• Participation in continuing education and national and/or regional organizations devoted