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:
The Research Project Manager will optimally manage the research portfolio for the Bariatrics Division of the Department of Surgery, which includes both interventional and observational human subjects research studies. He/she will work closely with the Principal Investigator(s), research designees, and administrative leaders to see research projects through from start to finish ensuring regulatory compliance and scientific integrity. The Research Project Manager is responsible for ensuring that studies are accurately carried out in accordance with institutional, state, and federal regulations, standard operating procedures, and required obligations to patient/subject, Principal investigator, research team, and Sponsor. The Research Project Manager is accountable for the day-to-day operations and execution of all study activities as well as assisting with grant or publication submissions upon request. The Research Project Manager will establish liaisons with School of Medicine, and NYU Langone Health that may include: Research Nurses, Research Pharmacists, Program Managers, Medical Technicians, Clinical Information Systems, and Regulatory Services such as FDA, IRB, and selective departments. The Research Project Manager will provide supervision, and training for research team members, student interns, and volunteer study staff as needed.
Job Responsibilities:
- Clinical Trial Management
- Protocol Development/Review
- Assist with developing research protocols as needed.
- Create informed consent and other study related documents as needed.
- Review research protocols including study proceedings and timelines, inclusion and exclusion criteria to determine study feasibility along with Principal Investigator.
- Develop source worksheets and case report forms as applicable.
- Set up, modify and maintain research database.
- Budget and Contracts
- Develop and negotiate budgets with sponsors in collaboration with Research Leadership and Office of Science and Research (OSR).
- Monitor budget throughout trial.
- Submit contracts to the legal department through Research Navigator.
- Initiate re-negotiation process if necessary during the trial period.
- Communicate with the Sponsor and OSR for any deviations from the contracts during the trial period.
- Ensure billing compliance is maintained according to best practices.
- Facilitate patient/subject payments for trial participation.
- Protocol Development/Review
-
- Regulatory Submission and Maintenance
- Create and maintain regulatory binders and patient/subject binders.
- Submit IRB initial, continuation, amendment, and study closure applications.
- Create, maintain and submit adverse event reports and safety reports to IRB.
- Submit and maintain study related documents as required by the Sponsor.
- Submit FDA applications, annual summary and adverse events reports when applicable.
- Study Conduct and Coordination
- Implementation of all clinical trial phases:
- Review all 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.
- Assist with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study.
- Schedule and conduct study visits, obtain and document information within the time frame specified.
- Collaborate with other departments throughout the study.
- Ensure investigational drug accountability and proper storing, handling, and dispensation.
- Collect, prepare, ship, and/or store biological materials using universal precautions.
- Provide reports to all necessary parties (e.g., the Principal Investigator, sponsoring agency, etc.) on the progress of the study as needed. Ensure successful recruitment and retention of study patients.
- Ensure successful study close-out.
- Ensure study team personnel adhere to Good Clinical Practice and compliance with NYUSoM and external regulatory agencies.
- Provide training to study team members when applicable.
- Study Inspections/Audits
- Facilitate and ensure successful internal inspections and audits.
- Facilitate and ensure successful FDA inspections and audits.
- Facilitate and ensure successful IRB QA inspections and audits.
- Implementation of all clinical trial phases:
- Regulatory Submission and Maintenance
- Reporting and Analysis
- Collaborate with clinical staff in ensure proper review of data, clarifications, interpretation and analysis for publications if requested by Principal Investigator.
- Researches, compiles and consolidates data and conducts preliminary analyzes to data collected for presentation to sponsoring and regulatory agencies if requested by Principal Investigator.
- Provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed.
- Generates preliminary measurement reports for review by Principal Investigator.
- Clinical Staff Goal Management
- Oversee and prepare all necessary data reports needed for clinician metrics as it relates to research.
- Coordinates and conducts monthly research meetings.
- Maintain up-to-date research profiles on all providers.
Minimum Qualifications:
Bachelor’s Degree plus three or more years related experience or equivalent combination of education and experience or a Master’s Degree plus one year of related work experience.
Quality Improvement experience suggested.
Computer literacy; proficiency using Microsoft Office applications such as Word, Excel, PowerPoint, and Outlook
Effective oral and written communication and interpersonal skills
Effective time management skills and ability to work well under pressure
Exceptional organization skills and attention to detail
Ability to work and make decisions independently. Demonstrated ability to troubleshoot and solve complex problems
Preferred Qualifications:
Clinical Research Coordinator (CRC) Certification 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 $67,771.14 – $112,951.35 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
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.
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.
Related Job Listings
Other Jobs That May Interest You
About NYU Langone Health
Be Where Everyone Is Dedicated to Exceptional Care
NYU Langone is a world-class, patient-centered, integrated academic medical center with Magnet®-recognized status by the American Nurses Credentialing Center (ANCC). Our trifold mission to care, teach, and discover is achieved daily through NYU Langone’s diverse and inclusive culture devoted to excellence across the organization. Here, you can advance your career supported by exceptionally talented faculty and staff in an environment where everyone works together to deliver the best possible outcomes for our patients.
Our Hiring Process
Joining Our Team
Get ready to start your career journey at NYU Langone, where cutting-edge research meets compassionate care, and discover how you can contribute to shaping the future of medicine.
Step 1
Apply Online
The NYU Langone hiring process begins with you applying through our online portal. Be sure to update and upload your resume. Shortly after you submit your application, you will receive an email confirmation. Ten days after applying you will receive a talent assessment to be completed.
Step 2
Schedule Interviews
If selected to continue the interview process, HR will reach out via phone or email first. Then, depending on your position, they will schedule an interview with unit managers or team members. You are encouraged to dress professionally for all interviews.
Step 3
Receive Offer
If you successfully complete the interview process and are identified as a finalist for the position, we will require that you complete a professional reference process. After evaluating the completed references, a decision will be made on who will receive a preliminary offer. If you receive a preliminary offer, HR will start the onboarding process with an agreed-upon tentative start date.
Step 4
Training & Orientation
You will be contacted by an onboarding specialist who will work with you on your pre-boarding requirements. Once fully cleared, we will ask you to complete compliance orientation regulatory training. On your first day, you will attend an online required orientation to acclimate to the health system and report to your new department based on instructions provided by your hiring manager.
Our Awards Reflect a Commitment to Excellence at Every Level
Hear From Our Team
Joseph O.
Refrigeration Engineer HelperIn my role, I provide a favorable atmosphere for our patients, visitors, employees, and students by ensuring their safety against fire hazards and by maintaining conducive temperatures throughout the seasons. I'm proud to work alongside my teammates to provide excellent service at a world-class organization that offers great opportunities to deserving candidates.
Jan 2018Security OfficerNov 2022Refrigeration Engineer Helper
Jane F.
Dental AssistantNYU Langone Health is a great place to work. I enjoy working with my colleagues as a team. NYU Langone offers training programs that allow us to grow within the organization. I feel valued as an employee.
Feb 2009Senior Nursing Assistant –
Stroke UnitMAR 2022Dental Assistant TraineeFEB 2023Dental Assistant
Noa L.
Supervisor, Patient Access CenterWhen I first began working at NYU Langone Health, I felt a sense of belonging and realized this is where I want to spend the rest of my professional career. Since joining, I've pushed myself to do well in every position I have and to advance. I not only enjoy my current role, but I also enjoy learning about new topics. I am excited to explore what else NYU Langone has to offer me in my career.
Nov 2021Access Center Representative IAug 2022Access Center Representative IIOct 2023Lead Access Center RepresentativeSept 2024Supervisor, Patient Access Center
Victoria L.
Senior Social WorkerGrowing up in New York City, I was aware of the prestige that NYU Langone Health held, so I decided to pursue a career at the premier health system after graduation. I enjoy helping, treating and supporting everyday New Yorkers and feeling like I make a difference. Working here, I feel like I am able to show up as my authentic self to assist our patient community.
Nov 2016Social WorkerJul 2022Senior Social Worker
I was fortunate to receive firsthand training from some of the founding team members of my department. This made my onboarding experience invaluable, and now I will get to pass on my knowledge and experience to future new hires within the department and pay it forward. The collaborative spirit at NYU Langone Health has created an excellent work culture where I can work alongside colleagues who share our same company vision to serve, teach and discover.
Nazneen H.
Clinical Charge Nurse Auditor in Revenue Management Initiatives