What are the responsibilities and job description for the Human Research Protections Manager position at NYU Grossman School of Medicine?
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, 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.
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Position Summary:
We have an exciting opportunity to join our team as a Human Research Protections Manager.
Reporting to Assistant Director, External Relations, the Manager is responsible for IRB submissions and Board-related processes related to the RECOVER study. The Manager serves as a point of contact for the RECOVER NYU study team as well as all relying site investigators, and facilitates IRB review of both study-wide and site-specific submissions.
Job Responsibilities:
Conducts comprehensive pre-review and post-review of RECOVER study-wide submissions, including modifications, continuations, and reportable new information.
Evaluate all RECOVER submission materials to determine consistency with IRB requirements for approval, including all NYU SoM Policies, applicable federal, state and local law and Good Clinical Practices and works with researchers to correct deficiencies prior to board review.
Write and relay clear and concise response review issues to PI through Research Navigator
Liaise with affiliate research committees and administrative staff (CTSI, PRMC, RPRG, COIC, OCT, SPA, ESCRO) to identify additional deficiencies and/or to determine that requisite approvals have been received
Serve as a designated reviewer of RECOVER study-wide and p-site submissions
Supervises RECOVER IRB meetings set up, member attendance and agenda
Attend board meetings as a voting member when necessary
Prepares for and attends RECOVER IRB meetings.
Records vote count during the RECOVER IRB meetings
Record all controverted issues and their resolution and Board determinations during RECOVER board meetings
Participate in debriefings following RECOVER Board meetings to verify understanding of the determinations
Generate all RECOVER board determination (approval and issue) letters documenting all IRB determinations
Drafts and manages dissemination of any correspondence for federal government reporting and ensures timely reporting to Federal to the Principal Investigator, Institutional Leadership and the Federal government ,OHRP and other agencies as needed.
Maintain a detailed log of all instances of non-compliance, UAPs, federal correspondence, allegations of non-compliance, and audit / RNI action items.
Develop, generate and distribute meeting minutes to the SSRM for pre-review, thereafter, IRB Director, prior to distribution to the Chair, Sr. HRP Director, and appropriate Board for review and approval
Verify the completeness and accuracy of each RECOVER board agenda item and the required documentation in accordance with NYU SOM IRB policies and procedures, applicable federal, state and local law and Good Clinical Practices
Manages and maintains the IRB channel on the RECOVER Teams platform.
Acts as a primary point of contact, offering guidance to RECOVER investigators and site personnel regarding compliance with sIRB processes, policies, and IRB decisions at both study and site levels.
Provides regular educational sessions to RECOVER investigators and site personnel, ensuring comprehension and adherence to protocols.
Offers input and proposes workflow process enhancements for all areas of responsibility, aiming to streamline operations and improve efficiency.
Attends regular team meetings to maintain consistency in workflow and processes.
Participates in HRP team meetings and other ad hoc meetings as necessary, fostering collaboration across divisions.
Assists the SSM or Assistant Director with special projects and protocol-specific issues as required, demonstrating flexibility and adaptability.
Undertakes any other duties as assigned, maintaining a collegial and efficient partnership with the research community.
Serves as a voting member during the Board meeting as required.
When necessary, conducts comprehensive pre-review and designated review of expedited modifications, continuations, and reportable new information
Provide vacation and sick coverage for other IRB Manager when necessary.
Minimum Qualifications:
To qualify you must have a Associates degree required OR Bachelor's Degree with relevant experience or the equivalent combination of education and experience. 3-5 years IRB regulations and documentation. 1-2 years Management or supervisory. Excellent communication (both oral and written), interpersonal, strong organizational, leadership, prioritization, problem solving and deductive reasoning skills. Knowledgeable of applicable federal regulations related to Institutional Review Board and Clinical research. Knowledgeable inHuman Subject Research. Basic computer skills including MS Office.
Preferred Qualifications:
Certified IRB Professional (CIP) (or will be required within 1 year of employment), Clinical Research Coordinator (CCRC) preferred
Qualified candidates must be able to effectively communicate with all levels of the organization.
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.
NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online.
View Know Your Rights: Workplace discrimination is illegal.
NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $67,771.14 - $95,000.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
To view the Pay Transparency Notice, please click here
NYU Langone Medical Center is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision.
Salary : $67,771 - $95,000
