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Senior Analyst Human Research Protection Program

Yale University – New Haven, CT

Position Focus:

The Senior Analyst, Human Research Protection Program (HRPP) is responsible for furthering the HRPPs 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.

Essential Duties

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 committees 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.

Required Skill/Ability 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.

Required Skill/Ability 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.

Required Skill/Ability 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.

Required Skill/Ability 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.).

Required Skill/Ability 5:

Detail oriented with proven organizational skills, analytical/problem solving abilities, and sound professional judgment.

Preferred Education, Experience and Skills:

Masters 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/independent IRB, non-profit/foundation, or an industry/corporate environment.

Preferred Licenses or Certifications:

Professional certification (e.g., Research Compliance Certification, Certified IRB Professional, or other research-related certification).

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

Drug Screen

No

Health Screening

No

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. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.

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 particular position. Employees will be assigned specific job-related duties through their hiring departments.

Affirmative Action Statement:

Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individuals 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. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the Universitys Title IX Coordinator, at [email protected], or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: [email protected]

Note

Yale University is a tobacco-free campus

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