Senior Research Compliance and Quality Specialist - HRPP Compliance

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. The 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, and contributing to departmental and cross‑departmental initiatives. On Campus Schedule Largely Remote; may require occasional on‑site presence a couple of times a year. Required Skills and Abilities Advanced knowledge of applicable legal, regulatory, and medical terminology and ability to interpret, analyze, apply, and communicate ethical principles, standards, regulations, guidance, policies, and industry trends that impact human research. Excellent interpersonal skills and demonstrated ability to collaborate with faculty, researchers, administrators, students, and agency representatives. Capacity to process a large volume of complex work, prioritize tasks, and adjust priorities as needed to meet conflicting demands. Proficient in office productivity software, including Word, PowerPoint, Excel, Outlook, and Adobe applications; able to learn new software rapidly. Detail‑oriented with strong organizational, analytical, and problem‑solving abilities. Preferred Education, Experience and Skills Master’s level or other advanced degree in law, nursing, public health, or related field. Five or more years of experience in institutional review board, research administration, or related research‑related roles at a large academic institution, hospital/medical center, academic/independent IRB, non‑profit/foundation, or an industry/corporate environment. Professional certification such as Research Compliance Certification, Certified IRB Professional, or other research‑related certification. Principal Responsibilities Review submissions and work with study teams to ensure that study materials are complete. Communicate with investigators and assist with preparation and editing of protocols, consent forms, and other study‑related documents to ensure compliance with university policies and applicable ethical and regulatory standards. Ensure necessary university, Yale‑New Haven Hospital (YNHH), ancillary committee, and other required approvals and agreements are complete for IRB review. Determine the type of review required for research studies and ensure proper categorization and routing. Ensure investigators are qualified and meet applicable requirements to serve as a principal investigator. Evaluate and analyze research studies to identify human subjects research issues and ensure submissions are ready for review. Apply ethical principles, regulations, guidelines, and policies to the review of research studies. Identify and resolve issues related to approvability or ongoing approval of submissions and escalate as necessary. Communicate findings and required modifications to investigators throughout the review process. Attend committee meetings, participate in discussions, and prepare meeting minutes and related correspondence. Ensure written information, determinations, and determination letters are accurate and complete. Assist with 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 standards. Serve as a member or consultant on university committees such as the Yale IRB and exercise delegated IRB chair signature authority to conduct expedited determinations. 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. Equal Employment Opportunity Statement Yale is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract qualified persons from a broad range of backgrounds and perspectives. Yale does not discriminate in admissions, educational programs, or employment against any individual on the basis of sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, or status as a special disabled veteran, veteran of the Vietnam era or other covered veteran per federal and state law. For inquiries concerning Yale’s Policy Against Discrimination and Harassment, refer to the Office of Institutional Equity and Accessibility (OIEA). #J-18808-Ljbffr