Senior Regulatory Analyst - Yale IRB

Senior Analyst, Human Research Protection Program (HRPP)

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Salary Range: $68,000.00 - $120,500.00

Job Requisition ID: 134064WD

Position Focus

The Senior 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 Senior Analyst will:

• 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;
• serve as a resource to researchers, study personnel, employees, students, fellows, and trainees regarding human research standards and institutional requirements;
• coordinate and facilitate the review of biomedical and behavioral research studies submitted for review and approval;
• 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
• 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. 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).

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.

Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.

Health Requirements

Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy.

Posting Disclaimer

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the position. Employees will be assigned specific job-related duties through their hiring department.

University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale's Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual's sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.

Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).

Yale University is a tobacco-free campus.