Careers in Quality

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 (with the Conflict of Interest office). For more information, refer to the HRPP website at Human Research Protection Program | It's Your Yale.

Position Summary

The Senior Analyst, Human Research Protection Program (HRPP) is responsible for furthering the HRPP’s mission by providing regulatory and administrative guidance and operationally supporting the committees managed by the HRPP. In the performance of duties for this position, the Senior Analyst will: (1) apply applicable ethical principles, standards, regulations, guidelines, policies, and academic and industry standards to ensure the protection of human research participants and the appropriate conduct of research; (2) serve as a resource and source of guidance regarding human research protection matters, institutional requirements related to human subject research, and other related regulatory issues; (3) ensure accuracy and maintenance of information that relates to research studies submitted for review; (4) foster effective written and oral communication, consensus building, and effective change management with co-workers and working groups; and (5) provide assistance to committee chairs and members that review human subjects research.

Principal Responsibilities

• Review submissions and work with the study teams to ensure that study materials are complete.
• Communicate with investigators and assist with the preparation and editing of protocols, consent forms, and other study-related documents to ensure that research that is presented for review is consistent with University policies and meets the applicable ethical and regulatory standards for review and approval.
• Ensure that necessary University, Yale-New Haven Hospital (YNHH), ancillary committee, and other required approvals and agreements are complete for a study submitted for IRB Review.
• Determine the types of review required for research studies to ensure they are properly categorized and routed for review.
• Ensure that investigators are qualified and meet applicable requirements to serve as a Principal Investigator for studies submitted for review.
• Evaluate and analyze research studies to identify human subjects research issues and ensure that the submissions are ready for review.
• Apply applicable ethical principles, standards, regulations, guidelines, and policies to the review of research studies, including the protocol, consent form, and other study-related documents.
• Identify and resolve issues related to the approvability or ongoing approval of submissions prior to their review and escalate matters as necessary.
• Route information and communicate study-related findings to the Principal Investigator or other designated individuals as appropriate throughout the review process and communicate and explain to the Principal Investigator any pre-approval, post-approval, or other required modifications related to a research study.
• Attend committee meetings, participate in discussion, and prepare meeting minutes and other correspondence that reflect the committee’s determinations as assigned.
• Ensure that written information and committee determinations and determination letters are accurate and complete.
• Assist with the review of compliance matters, reportable new information, assessments, inspections, and audits.
• Assist with departmental projects, cross-departmental initiatives, and training and education.
• Review, recommend, and revise applicable policies, standard operating procedures, work instructions, guidance, checklists, forms, and other documents to ensure compliance with applicable ethical principles, standards, regulations, guidelines, and policies.
• Serve as a member or consultant on a University committee such as the Yale IRB or other committee as requested and exercise delegated IRB Chair signature authority to conduct expedited determinations on behalf of the IRB.
• Other duties as assigned.

Required Education and Experience

Bachelor's degree in a related field and five or more years of research-related experience or an equivalent combination of education and experience.

Preferred Education and Experience

Advanced degree;  5 or more years HRPP/IRB, research administration, or other research-related experience at a large academic institution, hospital/medical center, academic/independent IRB, non-profit/foundation, or an industry/corporate environment; Research compliance certification, Certified IRB Professional (CIP), or other relevant certification such as SOCRA/ACRP (or equivalent).

Required Skills and Abilities

• Sophisticated knowledge of applicable legal, regulatory, and medical terminology and demonstrated expertise 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.
• Demonstrated ability to effectively interact and collaborate with a broad spectrum of individuals including faculty, patients, participants, researchers, administrators, students, agency representatives, and other professional contacts.
• Proven ability to process a large volume of complex work by prioritizing and organizing work and demonstrating flexibility and willingness to adjust priorities as necessary to meet conflicting demands.
• Strong software application skills and demonstrated ability to learn new software packages; highly skilled in office productivity software (g., Word, PowerPoint, Excel, e-mail, Outlook, and Adobe, etc.)
• Detail oriented with proven organizational skills, analytical/problem solving abilities, and sound professional judgment.

Work Location

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

Job Code

70258BR

TO APPLY: Go to the Yale University Career website at Senior Analyst, HRPP (Job Code 70258BR).  

For more information, refer to the Yale University Career Website at Search Jobs at Yale | It's Your Yale.

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.