Career Center

Yale University

Founded in 1701, Yale University is one of the world’s preeminent research universities.  Consistent with its mission, Yale is committed to improving the world today and for future generations through outstanding research and scholarship, education, preservation, and practice. Yale educates aspiring leaders worldwide who serve all sectors of society. For more information go to the Yale University website (About Yale | Yale University). Located in New Haven, Connecticut, Yale is 90 minutes from Providence, 2 hours from Boston, 90 minutes from New York City, 3 hours from Philadelphia, and 5 hours to Washington D.C. by car or train.  New Haven overlooks the Long Island Sound and is located near cities and towns with beaches, multiple state parks, including Sleeping Giant State Park just a few miles outside of New Haven, other forested areas, and lakes. Yale offers competitive salaries and vast benefit offerings including medical/dental/vision, retirement, paid time off (sick time, holidays, vacation days and additional flexible days, and recess days: the day after Thanksgiving, the day before Christmas, and the days between Christmas and New Year’s Day).

Research at Yale

Yale conducts more than $690 million of sponsored research each year, of which over 80% occurs through its Medical School, the remainder on its Central Campus with faculty from the Arts and Sciences. Yale has an integrated organizational model for research administration in order to achieve greater coordination and integration of policies, procedures, reporting and information systems, and to enhance the quality and efficiency of research administration services.

Yale Human Research Protection Program

The Human Research Protection Program (HRPP) oversees the review and approval of more than 3600 research studies annually. This includes biomedical and social behavioral research. The HRPP assists the University in meeting its legal, regulatory, and ethical obligations and routinely collaborates with other offices across the University and community partners on various programs and initiatives related to research that foster compliance, quality, efficiency, and the protection of human research participants. The HRPP’s goals are to: (1) Ensure the rights and welfare of human research participants; (2) Promote excellence in the conduct of research; and (3) Advance scientific knowledge and quality research. 

The Yale HRPP was first accredited by Association for the Accreditation of Human Research Protection Programs (AAHRPP) on 12/10/2010, and it has maintained its accreditation status since that time.  AAHRPP Accreditation indicates that our organization follows “rigorous standards for ethics, quality, and protections for human research”.

The HRPP includes the Yale University Institutional Review Board (IRB), which through its 19 IRB panels, serves as the IRB-of-record for Yale University studies, the  Yale  New  Haven  Hospital, and a  number  of  institutions through  Institutional Authorization Agreements (IAAs). The HRPP also supports the Radioactive Drug Research Committee (RDRC), Radioactive Investigational Drug Committee (RIDC), Embryonic Stem Cell Research Oversight Committee (ESCRO), and Institutional Conflict of Interest (ICIO) Committee (in collaboration with the Conflict of Interest Office). For more information, refer to the HRPP website at Human Research Protection Program | It's Your Yale.

Yale School of Medicine/Yale Center for Clinical Investigation

Since its inception in 2005, the mission of the Yale Center for Clinical Investigation (YCCI) has been to establish a home for the training of the next generation of clinical and translational scientists and to provide a robust infrastructure that promotes innovative and collaborative research directed at improving patient care. YCCI’s  key goals are to: (1) Attract talented students and junior faculty members from the Schools of Medicine, Nursing, Public Health, and Engineering into clinical and translational research careers; imbue them with a spirit of discovery; train them in the use of state-of-the-art research tools; and give them the skills needed to function collaboratively as members of multidisciplinary research teams; (2) Accelerate the movement of disease-related discoveries into the clinic by providing research teams with pilot grants, access to state-of-the-art research cores, and robust administrative, regulatory, informatics, biostatistics, and subject recruitment support for T1-T4 research: (3) Strengthen the infrastructure that connects clinical research teams with practitioners, community health clinics, and community stakeholders throughout Connecticut, reaching out in particular to diverse populations including children, women, the elderly, and underserved minorities; and (4) Work actively with other CTSA hubs to share research approaches, expertise, tools, data, and the integration of informatics systems and other key research functions. For more information about YCCI, please refer to  https://medicine.yale.edu/ycci/about/.

Position Summary

The Associate Director is responsible for leading, managing, and advising designated staff, teams, and/or areas within the Human Research Protection program (HRPP) and the Yale Center for Clinical Investigation (YCCI) and is responsible for independently identifying and resolving issues regarding the YCCI and the designated committees it supports.  The position works closely with YCCI and HRPP leadership, YCCI and 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 YCCI and HRPP-related initiatives; (4) Develop strategies to enable the YCCI and 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.

Reporting jointly to the Director, Human Research Protections Program (HRPP) within the Office of Research Administration (ORA) and the Senior Associate Director, Quality Assurance at the Yale Center for Clinical Investigation (YCCI), this position has key responsibilities in both Quality Assurance and also Regulatory & Compliance described as follows: 

• Quality Assurance: Development, implementation, and monitoring of an effective human research quality assurance program for investigators conducting research under the purview of the Yale designated IRB (defined as the Yale IRB or an external IRB authorized to provide review of research on behalf of Yale), including Yale School of Medicine, Faculty of Arts & Science, and other schools, departments, and affiliated entities where such research occurs. Specifically, this position coordinates the clinical research quality assessments for clinical trials conducted at the Yale Medical School (including the School of Public Health) and manages Quality Assurance efforts under the purview of the HRPP. This includes research conducted outside of the School of Medicine and committees supported by the HRPP office such as the IRB, RDRC, and RIDC. A critical component of the role is to identify to the Directors any safety and compliance concerns and recommend solutions to improve the overall operations, the safe and efficient conduct of clinical trials and educational and training opportunities for researchers and staff. The position is also responsible for the implementation of quality control measures to promote safety and compliance and the integration of QA in one or more review committees. 

• Regulatory and Compliance: Manage the AAHRPP accreditation process under the direction of the HRPP director, including revisions to policies, procedures, and other documents necessary to support the reaccreditation process; Serve as a key contact within the HRPP for agency inspections and communications with regulatory authorities; Provide support to for audits and inspections of investigators, the IRB, and RDRC; review agency reporting letters and communications with regulatory authorities; and assist with responses to University Auditing or Research Compliance audits and assessments; Oversees the HRPP’s internal policies; monitors HRPP operations to ensure compliance with regulations and institutional requirements; and trains investigators and staff regarding requirements. 

Principal Responsibilities

• 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.
• 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. 
• 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.
• 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. 
• 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.
• Leads, manages, and advises on matters related to HRPP accounts receivable, billing, and financial forecasting and reporting as assigned.
• 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.
• Leads, manages, advises, and delivers relevant education and training to the Yale University community and organizations external to Yale as assigned.
• Represents Yale at national meetings related to human research matters as assigned.
• 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.

Preferred Education and Experience

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.

Required Skills and Abilities

• 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.
• 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.
• 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.
• 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.
• 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).

Work Location

New Haven, CT (Position is Remote or Hybrid Eligible)

Job Code 

69863BR

TO APPLY: Go to the Yale University Career website at Associate Director, HRPP/YCCI-RCQ (Job Code 68693BR)

Yale University considers applicants for employment without regard to, and does not discriminate on the basis of an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression.