Senior Research Compliance and Quality Specialist – HRPP Compliance

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Position Focus

The Senior Research Compliance & Quality Specialist within the Human Research Protection Program (HRPP) at Yale is tasked with providing comprehensive support and quality assurance for human subjects research. This role involves overseeing compliance monitoring, conducting audits, and ensuring the integrity and ethical conduct of research. The specialist must be well-versed in federal, state, and local regulations governing human subjects research and possess strong analytical, communication, and organizational skills. They are also responsible for guiding and supporting research teams, ensuring adherence to regulatory requirements.

Reporting to the Associate Director of HRPP, the specialist conducts audits and compliance reviews for studies overseen by Yale's HRPP and Institutional Review Boards (IRBs). They investigate compliance issues, perform quality assurance activities, and identify opportunities for process improvements. The role includes providing direction and feedback to staff to ensure compliant completion of activities, contributing to departmental and cross-departmental initiatives, and offering education and training to study teams and the research community. Additionally, the specialist assists in developing and implementing Corrective and Preventive Action plans, oversees regulatory matters, and supports other compliance activities, including handling reportable new information submissions and agency inspections. Other duties may be assigned as needed.

On Campus Schedule: Largely Remote

Required Skill and Abilities

1. 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.
2. 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.
3. 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.
4. Strong software application skills and demonstrated ability to learn new software packages; highly skilled in office productivity software (e.g., Word, PowerPoint, Excel, e-mail, Outlook, and Adobe, etc.)
5. Detail oriented with proven organizational skills, analytical/problem solving abilities, and sound professional judgment.

Preferred Education, Experience and Skills

1. A Master’s level or other advanced degree in law, nursing, public health, or related field and five or more years Institutional Review Board, research administration, or other relevant research-related experience at a large academic institution, hospital/medical center, academic/independent IRB, non-profit/foundation, or an industry/corporate environment.
2. Professional certification (e.g., Research Compliance Certification, Certified IRB Professional, or other research-related certification).

This position is mainly remote but may require to be on site a couple times a year.

Principal Responsibilities

1. Review submissions and work with the study teams to ensure that study materials are complete.
2. 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.
3. 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.
4. Determine the types of review required for research studies to ensure they are properly categorized and routed for review.
5. Ensure that investigators are qualified and meet applicable requirements to serve as a Principal Investigator for studies submitted for review.
6. Evaluate and analyze research studies to identify human subjects research issues and ensure that the submissions are ready for review.
7. 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.
8. Identify and resolve issues related to the approvability or ongoing approval of submissions prior to their review and escalate matters as necessary.
9. 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.
10. Attend committee meetings, participate in discussion, and prepare meeting minutes and other correspondence that reflect the committee’s determinations as assigned.
11. Ensure that written information and committee determinations and determination letters are accurate and complete.
12. Assist with the review of compliance matters, reportable new information, assessments, inspections, and audits.
13. Assist with departmental projects, cross-departmental initiatives, and training and education.
14. 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.
15. 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.
16. 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.