University Job Title
Associate Director, HRPP **
Bargaining Unit**
None - Not included in the union (Yale Union Group) **
Time Type**
Full time **
Duration Type**
Regular **
Compensation Grade**
Administration & Operations **
Compensation Grade Profile**
Manager; Program Leader (28) **
Wage Ranges**
Click here to see our Wage Ranges **
Searchable Job Family**
Administration **
Total # of hours to be worked:**
37.5 **
Work Week**
Standard (M-F equal number of hours per day) **
Work Location**
Central Campus **
Worksite Address**
150 Munson Street
New Haven, CT 06511 **
Work Model**
Remote **
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. **
Essential Duties**
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. **
Required Skill/Ability 1**
Demonstrated mastery of human research related standards and expert ability to interpret, analyze, apply, and communicate applicable ethical principles, laws, regulations, guidance, policies, academic and industry trends, and other standards that apply to human research. **
Required Skill/Ability 2**
Expert ability to lead, organize, and execute on complex projects; multi-task, identify, analyze, and resolve problems efficiently and effectively; use independent good judgment and to assess risk; and independently follow-through on tasks, develop and execute work plans, prioritize work, and manage multiple assignments to meet deadlines. **
Required Skill/Ability 3**
Expert ability to evaluate information; formulate logical and objective conclusions; make recommendations for effective solutions, strategies, and approaches; and to distill and communicate complex information into understandable information. **
Required Skill/Ability 4**
Demonstrated ability to provide proactive, flexible, and customer service focused advice; work effectively with others; and demonstrate ethics and integrity in a professional matter, sensitivity to confidentiality, and a commitment to protecting research participants. **
Required Skill/Ability 5**
Demonstrated technology and software application skills; ability to learn new software packages; highly skilled in office productivity software (e.g., Word, PowerPoint, Excel, e-mail, Outlook, and Adobe, etc.); and knowledge of technology platforms used in research (e.g., IRB management, clinical trial management, and related platforms). **
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. **
Drug Screen**
No **
Health Screening**
No **
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. **
COVID-19 Vaccine Requirement**
Required
The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines **
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. **
EEO Statement**
University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.
Inquiries concerning Yale’s Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA). **
Note**
Yale University is a tobacco-free campus
NHS Scotland
On-Ramps
Lumanity
Medpace
