Human Research Protections Senior Analyst

NYU Langone Health • New York, NY

4d • $66,300 - $80,000

About The Position

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health [http://nyulangone.org], the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge.

For more information, go to med.nyu.edu [http://med.nyu.edu/], and interact with us on LinkedIn [https://www.linkedin.com/company/nyulangonehealth/?viewAsMember=true], Glassdoor [https://www.glassdoor.com/Reviews/NYU-Langone-Health-Reviews-E121521.htm], Indeed [https://www.indeed.com/cmp/Nyu-Langone-Health/reviews], Facebook [https://facebook.com/NYUSchoolofMedicine], Twitter [https://twitter.com/nyuschoolofmed] and Instagram [https://instagram.com/nyuschoolofmed].

We have an exciting opportunity to join our team as a Human Research Protections Senior Analyst.

Reporting to the Senior Scientific Manager (SSM), the Sr Analyst is responsible for conducting pre-reviews of Continuing Reviews, Closures, and Modifications, placing items on the Full Board agenda and suggesting reviewers, and issuing approval letters for Full Board and expedited Mods/CRs. The Sr. Analyst attends weekly pre-board meetings to discuss assigned agenda items, manages daily CR and Mod assignments, and follows up on Full Board CR/Mod clarifications and deferral responses. The Sr. Analyst also develops and distributes meeting agendas, confirms Board member attendance, and obtains alternates as needed.

Requirements

• BA/BS required or 2 years working experience within an IRB Administrative Office performing similar responsibilities.
• Certified IRB Professional or must be able to obtain certification as an IRB Professional within 24 months of hire.
• Excellent interpersonal skills.
• Demonstrably skills in professional oral and written communication. Able to deal efficiently and effectively with high volumes, rigid deadlines, and frequent changes.
• Working knowledge of regulations governing humans subjects research.
• Ability to interpret regulations, apply regulations to written protocols, and convey information verbally and in writing to faculty and staff.
• Ability to set priorities and manage time effectively.Ability to perform multiple tasks at any given time with a high level of accuracy and attention to detail.
• Diplomacy and strong customer service skills and knowledge.Independent initiative.
• Ability to work with all levels of employees in a respectful and supportive manner.Highly proficient with MS Outlook, Word and Excel, with a working knowledge of MS Access.
• A commitment to help maintain a positive, productive and healthy office environment

Nice To Haves

• Prior experience overseeing work flow processes is preferred
• Qualified candidates must be able to effectively communicate with all levels of the organization.

Responsibilities

• Conduct pre-review of modifications, continuations, and closures in accordance with federal regulations, applicable federal, state, and local laws, Good Clinical Practices, and HRP policies and procedures
• Write and relay clear and concise pre-review issues to PIs through official pre-review correspondence via email
• Conduct regular follow-up with PIs on all outstanding issues resulting from pre-review correspondence
• Work with researchers to revise submissions and prepare for final board review
• Verify the completeness and accuracy of each application and the required documentation using appropriate review checklists
• Issue all decisions and record all communications with research teams in Research Navigator
• Conduct post-review for all assigned expedited submissions
• Assign reviewers for Full Board submissions consistent with reviewers medical and scientific expertise where appropriate.
• Oversee development and distribution of each meeting agenda.
• Confirm Board primary or alternate member meeting attendance for the whole year and monthly before the specific meeting.
• Conduct a review of all Continuing Review, Modification, and responses on full board agenda in preparation for full Board meetings.
• Attend weekly pre-Board meetings to discuss items assigned to relevant Full Board meeting agendas.
• Generate and distribute approval letters documenting IRB approval determinations for Full Board continuations and modifications.
• Conduct regular follow-up with PIs on all outstanding issues resulting from Board review for all Conditional Approvals and Deferrals for Full Board modifications and continuations.
• Verify the completeness and accuracy of Conditional Approval and deferral responses for full Board continuing review and modification agenda items in accordance with NYU SOM IRB policies and procedures, applicable federal, state and local law and Good Clinical Practice.
• Assign new modification and continuation submissions and complete data entry in the Distribution Tracker.
• Upload electronic email communication from CRSU/Contracts regarding required changes to the informed consent form to Research Navigator.
• Provide guidance and assistance to the research staff to educate and assist them in their activities.
• Work with the IRB Education Manager to develop PowerPoint presentations and participate in education and training sessions for the research community.
• Assist the SSM with special projects and protocol-specific issues.

Benefits

• NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents.
• At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package.
• Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement.
• The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support.
• Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care.
• The benefits and wellness package is designed to allow you to focus on what truly matters.
• Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees