Associate Director, Hrpp

Essential Duties

1.Leads, manages, and advises on regulatory matters as assigned.

This includes serving as an expert resource regarding applicable laws, regulations, and standards governing human subjects research conducted in the United States and other countries; providing advice and ensuring the efficient review, identification, and resolution of regulatory issues with a focus on customer service and compliance; and delivering relevant training. 2.

Leads, manages, and advises on compliance matters as assigned.

This includes leading, managing, and advising on the following: human research oversight activities (e.g., internal and external reviews, audits, and inspections); systematic reviews that evaluate researcher and study team compliance with IRB approved protocols and applicable laws, regulations, and standards; and the oversight, investigation, and escalation of compliance issues and complaints. 3. Leads, manages, and advises on quality matters (quality control, quality assurance, and quality improvement) as assigned.

This includes leading, managing, and advising on the following: HRPP quality; post-IRB approval monitoring of research studies and other quality improvement activities; reporting and tracking of audit and monitoring findings and reports requested from sponsors, federal agencies, and other oversight bodies; and ensuring that periodic audits of the internal and external IRBs are conducted to ensure compliance.4. Leads, manages, and advises on operational matters and ensures operational efficiency and compliance with laws, regulations, and standards related to the conduct of human research.

This includes leading, managing, and advising on the following: departmental and cross-departmental initiatives, projects, and requests for assistance by the University community; delivery of day-to-day service levels, customer experience, and quality measures; change management within the HRPP; collaborations with other business units; strategic objectives set forth by the HRPP and University; operational effectiveness and strategies to ensure quality and efficiency; operational opportunities, risk management, and continuous quality improvement; and verifying that institutional requirements have been satisfied. 5. Leads, manages, and advises on relationships external to the HRPP office and University as assigned.

This includes facilitating discussions with research investigators, program directors and high-ranking officials from external institutions or organizations who are interested in pursuing a collaborative research affiliate relationship with Yale University; collaborating with ancillary committees, departments, and organizations external to Yale regarding human research matters; and managing reliance and other agreements. 6.

Leads, manages, and advises on matters related to HRPP accounts receivable, billing, and financial forecasting and reporting as assigned. 7. Leads, manages, and advises on medical and scientific matters related to human research protection program matters as assigned.

This includes safety monitoring; study and reportable new information review; assistance with protocol, consent, study-related document writing and editing; IRB quality control; training; and other advice related services. 8.

Leads, manages, advises, and delivers relevant education and training to the Yale University community and organizations external to Yale as assigned. 9. Represents Yale at national meetings related to human research matters as assigned. 10. Other Duties as assigned.

Required Education and Experience

Bachelor's degree; 10 years of relevant experience in research administration or human subject protection with 7 years prior experience at a large academic institution, hospital/medical center, academic/independent IRB, or non-profit organization/foundation; or an equivalent combination of education and experience.

Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.

Position Focus:

The Associate Director, Human Research Protection Program (HRPP) is responsible for leading, managing, and advising designated staff, teams, and/or areas within the HRPP office and is responsible for independently identifying and resolving issues regarding the HRPP and the designated committees it supports. The position works closely with HRPP and IRB leadership, HRPP staff, IRB members, ancillary committee leadership, and others in the University research community to ensure operational efficiency and compliance with laws, regulations, standards, and institutional requirements that impact human research.

In the performance of duties, the position will: (1) Review, research, and interpret changes, trends and new developments related to human research; (2) Provide written analysis on specified topics; (3) Draft policies and procedures to implement and operationalize HRPP-related initiatives; (4) Develop strategies to enable the HRPP and other implicated University Departments and personnel to successfully adapt to changes; and (5) Serve as a resource to the University community regarding human research matters. In this role, the Associate Director also will be responsible for the following: Regulatory

• Staying apprised of regulatory requirements and providing updates to key stakeholders. Compliance

• Managing AAHRPP reaccreditation, including revising policies, procedures, and other documents; Serving as a key contact within the HRPP for agency inspections and communications with regulatory authorities; Providing support for audits and inspections of investigators, the IRB, and other committees under HRPP; review agency reporting letters; Assisting with responses to audits; Monitoring HRPP operations to ensure compliance with regulations and institutional requirements. Quality

• Developing and monitoring an effective human research quality assurance program for investigators, office operations, and committees under the oversight of the HRPP. Education

• Developing and delivering training and education for key stakeholders in the research community. Relationship between YNHHS and Yale University

• Establishing and overseeing the relationship between the Yale New Haven Health System (YNHHS) and Yale University stakeholders to (i) facilitate integration of YNHHS research into the portfolio of research subject to HRPP oversight and (ii) ensure compliance with HRPP and YNHHS policies, AAHRPP standards, YNHHS assurance, and ethical/regulatory requirements governing human subjects research; Investigating reports of potential serious/continuing noncompliance involving investigators from YNHHS, advising the IRB on adequate Corrective and Preventative Action (CAPA) Plans and overseeing implementation; Providing regulatory support during agency audits/ monitoring visits including preparation of institutional responses following an audit; Coordinating the flow of information between the HRPP/IRB and YNHHS regarding institutional/individual conflicts of interest, contractual obligations related to human subjects research, etc.; Advising the HRPP on issues related to reliance agreements between entities within the YNHHS and external IRBs; Monitoring the quality of research submissions by YNHHS investigators and analyzing trends in reported incidents of noncompliance to identify areas for improvement; Advising YNHHS on issues related to expansion of research into new areas and integration of research conducted at system acquired practices and hospitals (e.g., overseeing transfer of IRB oversight and onboarding investigators); Monitoring ongoing costs related to HRPP oversight of YNHHS system and assisting with projections based on trends; Reviewing YNHHS exempt research, proposals for Quality Improvement Projects, and requests for Not Human Subjects Research determinations.

Preferred Education, Experience and Skills:

Advanced degree (JD, PhD, MD, etc.); Research Compliance, Certified IRB Professional, or other relevant certification; Project, quality, or lean management certification; Experience in a leadership or consultancy role; Expert knowledge regarding Federally Funded/FDA regulated research regulations, ICH GCP, and the clinical trials process; and experience with international research standards.

Posting Disclaimer

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.