Regulatory Analyst Human Research Protection Program (HRPP)

Overview

The Analyst, Human Research Protection Program (HRPP) supports the Yale HRPP and University’s  research mission by providing guidance and support to the committees managed by the HRPP, including the Yale designated IRB (e.g., the Yale IRB or an external IRB authorized by the Yale Human Research Protection program (HRPP) to provide review of Yale research on behalf of Yale). In the performance of duties for this position, the Analyst will: (1) apply  relevant ethical principles, regulations, guidelines, policies, and other standards to ensure the ethical protection of human research participants, compliance, and the appropriate conduct of research; (2) serve as a resource to researchers, study personnel, employees, students, fellows, and trainees regarding human research standards and institutional requirements; (3) coordinate and facilitate  the review of biomedical and behavioral research studies submitted for review and approval; (4) Demonstrate quality, productivity, efficiency, innovation, accountability, consensus building, teamwork, customer service, professionalism, inclusiveness, problem solving, and effective communications skills in all work performed by the HRPP office; and (5) Demonstrate ethics, integrity, organizational commitment, and  alignment with the HRPP and Yale’s missions and goals.

On Campus Schedule: Largely Remote

Required Skill and Abilities

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

Preferred Education, Experience and Skills

Three 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 organization/foundation, or an industry/corporate environment.

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. Other duties as assigned.

Required Education and Experience

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