Institutional Review Board Manager
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- 1131054_RR00093044
- Research, NYU Grossman School of Medicine, OSR HRP-Operations (S1603)
- Full-Time/Regular
- NYU Grossman School of Medicine (SOM)
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- Monday – Friday 9:00 am – 5:00 pm
ABOUT NYU LANGONE HEALTH
NYU Langone Health is a world-class, patient-centered, integrated academic medical center. Ranked as the #1 Hospital for quality and patient safety by Vizient, Inc., and with 10 clinical specialties among the top 10 in the nation according to U.S. News & World Report, NYU Langone’s culture is rooted in excellence in patient care, education, and research. NYU Langone comprises more than 320 locations throughout the New York area and in Florida, including six inpatient locations, a children’s hospital, and four emergency rooms. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute designated comprehensive cancer center, NYU Grossman School of Medicine, and NYU Grossman Long Island School of Medicine. For more information, go to nyulangone.org, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, Twitter, YouTube, and Instagram.
Working at NYU Langone Health
NYU Langone Health isn’t just a healthcare system; we’re also a research hospital with a mission to advance science and improve healthcare. We offer a collaborative approach to research that spans disciplines, pairing outstanding scientists with exceptional clinical researchers. This approach sparks new ideas and discoveries that lead to innovative advances in preventing, diagnosing, and treating disease. With access to state-of-the-art technologies and facilities, our scientists and researchers have pioneered groundbreaking medical treatments used around the world.
Salaries shown on independent jobs related websites reflect market averages and do not represent information obtained directly from NYU Langone. We invite and encourage each candidate to discuss salary/hourly specifics during the application and hiring process.
Job Details
Position Summary:
We have an exciting opportunity to join our team as a Institutional Review Board Manager. Please note this position is open to hybrid and remote working conditions.
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
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.
Qualifications
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:
Bachelor’s Degree In aHealth care related field. Certification for IRB Professionals (CIP).
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.
NYU Grossman School of Medicine 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. We require applications to be completed online.
If you wish to view NYU Grossman School of Medicine’s EEO policies, please click here. Please click here to view the Federal “EEO is the law” poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information.
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 – $112,533.27 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
Organization
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, diversity, 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 diversity, inclusion, and individual skills, ideas, and knowledge. For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, Twitter and Instagram.
How Our Employees Grow
Jason A.
Data Analyst
“NYU Langone Health offers an abundance of opportunities to grow and develop in a healthy work environment. I enjoyed using NYU Langone’s training curriculum courses in business to support my career progression and I also utilized the Tuition assistance program to obtain a Master of Public Health (MPH). I’m proud of my work and what the organization represents to New York City and the surrounding communities.”
Tiffany M.
Research Coordinator
“The collaborative and supportive environment at NYU Langone Health has cultivated a sense of camaraderie that makes coming to work each day incredibly fulfilling. I am grateful for the mentorship provided by my esteemed faculty members, which has played a vital role in my professional development. NYU Langone has also provided me with incredible opportunities to learn and grow through their tuition assistance to pursue my Master of Public Health (MPH) at New York University and in-house training curriculum.”
Tanisha D.
Program Coordinator
“I saw that there were many opportunities to grow within the organization and used the tuition remission offering at NYU Langone Health to obtain my master’s degree. NYU Langone celebrates their employees and genuinely wants to hire from within, so take advantage of the resources available to you and speak to members of the Talent Acquisition Team, who are helpful.”
Ivelisse M.
Division Administrator, Hematology and Medical Oncology
“NYU Langone Health is truly a place full of endless opportunities for growth. I’ve always been fortunate to have great managers who fostered my desire to learn, innovate, and grow. My experience at NYU Langone has shaped me into who I am today. Here, you are part of a community and a family ― it is more than just a job, it is something to be proud of.”
Terry L.
Sr. Research Coordinator―Psychiatry Mood & Anxiety Disorders
“Working here has been incredibly fulfilling. I would encourage my fellow veterans to follow in my path at NYU Langone Health. What started as an internship has led to a 22-year career. I hope to pursue my doctorate degree net, thanks to the generous benefits available to me.”.
Kai-ama H.
Associate Director, ParentCorps
“My favorite moment is when a previous supervisor recognized my potential and asked me to consider becoming a supervisor. I was hesitant but her encouragement, belief in my abilities, and desire to see me grow, propelled me into becoming a leader. It changed what I believed was possible for me. If you are looking for a challenging work environment to leverage the skills you already have while building new expertise, NYU Langone Health is the place to be!”
Latoya K.
Program Manager
“NYU Langone Health’s reputation was a motivating factor in building my career here. As a world-renowned institution at the forefront of medical advancement, NYU Langone provides staff with various training courses that allow for further career development.”
Haleigh T.
Senior Residency/Fellowship Program Coordinator
“My motivation to build a career at NYU Langone Health is to continue to work for an institution that values and celebrates its team members and promotes professional advancement. I feel that my role on the NYU Langone team makes a difference because of my contribution to its educational mission through my work with the fellows and faculty in their educational and professional pursuits.”