Research Regulatory Specialist
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- 1126141_RR00089298
- Research, Medicine-Gastro + Hepatology (S584), NYU Grossman School of Medicine
- 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.
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.
Position Summary:
We have an exciting opportunity to join our team as a Research Regulatory Specialist.
Serve as liaison between research sponsors, CRO, IRB and internal departments or staff to ensure compliance and management with study requirement and initiatives. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and the sponsor. Partners with respective internal and external teams as needed; Interfaces directly with patients/subjects and the Principal Investigator in support of the clinical trials if applicable. Provides guidance to Research support staff.
Works autonomously and with limited oversight.
Job Responsibilities
- Financial/Protocol Development Develops draft budget, monitors budget throughout trial and recommends staffing levels based on reviewed protocol. Reviews sponsor-proposed budget for adequate coverage and recommends changes as appropriate. Develops draft and final budgets together with study/project leader. Preparation of funding reports to funding agencies. Might identify new potential sponsors/agents for trials and researches and participate in the development of protocols as assigned.
- NYU Office of Clinical Trials/IRB If applicable, oversee the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials in order to obtain approval to conduct human subjects research. Secures accurate signatures and forwards documents and/or forms to appropriate destination. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, research team and the sponsor. Monitors any outward effects or issues regarding patient/subject safety and reports this to the appropriate party. Might oversee the monthly enrollment statistics submission to the Office of Clinical Trials, and provides other information in timely manner, as necessary.
- Reporting and Data Analysis Prepares progress reports to funding agencies and presentations to sponsoring and regulatory agencies. Prepares and provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Recommends changes/additions to established data fields. Analyses data collected, formulates, prepares database and generates a complete measurement report for review by the director. May oversee staff assigned to this responsibility.
- Study Regulations – Aware of study regulatory status and keep an up to date copy of regulatory documents. Assists with the informed consent process and ensures that the patient/subject fully understands what is required of them throughout the study. Monitors any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, Physician and Research Nurse. Assists with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Reminds patient/subjects of visits and compliance in a consistent manner.
- Project Management – Oversees planning/management of study activities and of multiple projects as assigned. Reviews progress of projects and initiate appropriate actions to achieve target objectives.
- Grants – Oversees the preparation of grant applications and other grants related activities such as developing grants applications/proposals and fund raising activities if applicable. Collects and organizes required paperwork for submission if required for the grant. Follow up and coordinates resolution of all issues progress reports to the sponsors to fund medical research in the division.
- Recruitment – Manages the recruitment process for study/program. Screens potential patients/subjects for eligibility to the study. This may include gathering information from the medical record, physician referral,advertisement and directly scheduling a visit to evaluate the patient/subject. Reviews all the elements of the screening process with the Principal Investigator that being: inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study.
- Decision Making and Problem Solving Combines and evaluates information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Resolves complex situations based on established policies and procedures and refers non solved issues and questions to the supervisor.
- Provides guidance, training, leadership to less experienced staff. May have input into staff evaluations.
- Participates in special projects and performs other duties as required.
Minimum Qualifications:
To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related discipline. Minimum of four years of progressively responsible related experience coordinating clinical/research trials studies. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective oral, written, communication, interpersonal skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Ability to work and make decisions independently. Time management skills and ability to multi task. Strong understanding and knowledge base of coordination requirements associated with
clinical/research trials. Ability to identify, analyze and solve problems; ability to work well under pressure.
Preferred Qualifications:
Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines). Knowledge of basic medical
terminology is 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.
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 $62,400.00 – $77,168.00 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
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.”