Senior Research Regulatory Specialist
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- 1130763_RR00093716
- Research, NYU Grossman School of Medicine, Perlmutter CancerCtr (S580)
- Full-Time/Regular
- NYU Grossman School of Medicine (SOM)
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- Monday – Friday; 9:00AM – 5:00PM
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 Senior Research Regulatory Specialist. The Senior Regulatory Specialist will be responsible for programmatic support to initiate clinical trials. Reporting to the Manager of Regulatory Affairs Unit, your specific responsibilities will include all pre-activation responsibilities. You will serve as the internal project manager for the specific oncology disease group(s) for which you are assigned and provide the group timely updates on the status of submissions and regulatory guidance on study development. Additionally you will serve as the liaison between the sponsor, CRO, IRB, FDA and internal departments/ staff. The Senior Regulatory Specialist will be responsible for ongoing maintenance of essential documents, IRB submissions and communication with the sponsor throughout the course of the study until study termination. You will also provide mentorship and onboard to Regulatory Assistants and Regulatory Specialists.
Job Responsibilities
Job Responsibilities:
Initiating contracts & budgets of clinical trials in the internal system (CDA’s & CTA’s) for completion by the appropriate legal department at NYU and managing their completion to ensure timely activation.
Directly communicate with local and national regulatory authorities.
Complete site qualification questionnaires from potential industry sponsors and analyze PCC ability to participate.
Conduct pre-study visits to ensure site meets all requirements to conduct the clinical trial are met.
Creation of regulatory master files for industry & investigator initiated oncology trials.
Develop trial specific patient informed consent forms for highly complex clinical trials (phase 0, 1, 1/2, 2, and 3).
Contribute to the development and implementation of local protocols and grants (including consent forms, study calendars, letter of intents (LOIs)), and single patient IND’s to ensure they conform to the sponsor & NYU specifications.
Organizing and preparing site initiation visits with sponsor/CRO & clinical team.
Assist the clinical team in the development of trial specific training tools for the study staff.
Collaborate with investigators to prioritize the submission and activation of clinical trials.
Timely submission of all regulatory documents to ensure that activation timelines are met and track and control all regulatory submissions and disseminate approvals.
Prepare, submit and obtain initial approval from mandatory scientific review committees (In-house: Protocol Review and Monitoring Committee, Institutional Review Board, Biosafety Committee, Conflicts of Interest Committee and Radiation Committee. External: FDA, NIH, NCI, Cooperative Groups).
Provide regulatory counsel and guidance to study members.
Mentor junior regulatory staff.
Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects.
Aid in the development of departmental standard operation procedures.
Maintenance of regulatory master files for industry & investigator initiated oncology trials
Submission of study amendments in a timely fashion including changes to the protocol, consent forms and other study documents.
Accurate preparation of annual renewals & study closure for IRB & sponsors.
Upload any contractual or budgetary changes in internal system for completion by appropriate department at NYU
Assist the clinical team with the development and implementation of amendments
Obtain continuing approvals from various committees and organizations (In-house: Scientific Committee, Institutional Review Board, Biosafety Committee, Radiation Committee.
Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects
Aid in the development of protocol specific standard operation procedures
Provide mentorship and training to junior regulatory staff
Provide regulatory coverage for other Disease Management Groups as need
Participate audits conducted through the internal audit committee
Participate in workgroups and SOPs related to regulatory processes and workflows
Perform additional duties as required
Qualifications
Minimum Qualifications:
To qualify you must have a Bachelor’s degree.
3 years of research related experience in oncology; and a working knowledge of government codes/regulations is required.
Excellent working knowledge of regulatory compliance requirements and procedures Knowledge of MS Office suites, database, spreadsheets, graphic and communications applications.
Extensive knowledge of oncology clinical trials and oncology terminology required.
Exceptional communication, analytical, presentation and time management skills.
Ability to demonstrate impact on project goals through proactive solutions and keeps management aware of project schedules/timelines.
Preferred Qualifications:
Master’s degree in a relevant discipline such as Public Health, Health Administration or a relevant science is highly desirable.
Minimum of 4 years or comparable experience in hospital planning and operations; and a working knowledge of government codes/regulations is required.
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 – $96,515.12 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.”