Research Project Manager
: Job Details :

Job DescriptionNYU 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.*

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.** 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 Masters Degree plus one year of related work experienceQuality Improvement experience suggested.Computer literacy; proficiency using Microsoft Office applications such as Word, Excel, PowerPoint, and OutlookEffective oral and written communication and interpersonal skillsEffective time management skills and ability to work well under pressureExceptional organization skills and attention to detailAbility to work and make decisions independently. Demonstrated ability to troubleshoot and solve complex problemsPreferred 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 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 hereSalaries 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.Company Location NYU Grossman School of Medicine Department Surgery-Bariatrics FGP (S503) Position Type Full-Time/RegularShiftMonday to Friday; 9:00AM - 5:00PM