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. 8. Other Duties as assigned.
Preferred Education: Advanced degree preferred (JD, PhD, MD, etc.). Research Compliance, Certified IRB Professional, or other relevant certification. Experience in a leadership/consultancy role. Expert knowledge regarding Federally Funded/FDA regulated research regulations, ICH GCP, and the clinical trials process. Experience with international research standards.
Preferred Education, Experience and Skills: Advanced degree preferred (JD, PhD, MD, etc.). Research Compliance, Certified IRB Professional, or other relevant certification. Experience in a leadership/consultancy role. Expert knowledge regarding Federally Funded/FDA regulated research regulations, ICH GCP, and the clinical trials process. Experience with international research standards.
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.). Knowledge of technology platforms used in research (e.g., IRB management, clinical trial management, and related platforms).
Posting Position Title: Assistant Director, HRPP
Required Skill/ability 3: Demonstrated ability to evaluate information, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies and approaches. Ability to distill and communicate complex information into understandable information.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Senior Advisor
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 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. Demonstrated ethics and integrity in professional matters, sensitivity to confidentiality, and commitment to protecting research participants.
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.
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.
Internal Number: 58501BR
About Yale University
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.