Yale School of Medicine

This includes leading, managing, and advising on the following: human research oversight activities (, 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.. 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.. Required Education and Experience Bachelor’s degree in a relevant scientific, legal, public policy, or business discipline; 7 years of relevant experience in research administration or human subject protection with 5 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.. ; and knowledge of technology platforms used in research (, IRB management, clinical trial management, and related platforms).. Physical Requirements Physical Requirements: 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.

protection

Position Focus: The Assistant 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. 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 (, 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. 8. Other Duties as assigned. Required Education and Experience Bachelor’s degree in a relevant scientific, legal, public policy, or business discipline; 7 years of relevant experience in research administration or human subject protection with 5 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 expertise and a comprehensive understanding of applicable legal, regulatory, and medical terminology and ability to interpret, analyze, apply, and communicate (verbally and in writing) applicable ethical principles, standards, regulations, guidance, policies, and academic and industry trends that impact human research. Required Skill/Ability 2: Demonstrated ability to manage, organize, and execute 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: Demonstrated ability to evaluate information, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and approaches; and ability to distill and communicate complex information into understandable information. Required Skill/Ability 4: Demonstrated ability to provide guidance regarding regulatory requirements and resolve issues; proactive, flexible, and customer service focused with the ability to work effectively with others; and demonstration of ethics and integrity in professional matters, sensitivity to confidentiality, and 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 (, Word, PowerPoint, Excel, e-mail, Outlook, and Adobe, etc.); and knowledge of technology platforms used in research (, IRB management, clinical trial management, and related platforms). Physical Requirements Physical Requirements: 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 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: 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.

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