Research Project Manager - Bariatrics Surgery - NYU Langone

New York, NY 10016

About the Job

NYU Grossman School of Medicineis 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 ofNYU 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 tomed.nyu.edu, and interact with us onLinkedIn,Glassdoor,Indeed,Facebook,TwitterandInstagram.

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
- ProtocolDevelopment/Review
  - Assistwith developingresearchprotocolsasneeded.
  - Createinformedconsentandotherstudyrelateddocumentsas needed.
  - Review research protocols including study proceedings and timelines, inclusionandexclusioncriteriatodeterminestudyfeasibilityalongwith Principal Investigator.
  - Developsourceworksheets andcasereport formsas applicable.
  - Setup,modifyandmaintainresearchdatabase.
- BudgetandContracts
  - Developandnegotiatebudgetswithsponsorsincollaborationwith Research Leadership and Office of Science and Research (OSR).
  - Monitorbudgetthroughouttrial.
  - Submitcontractstothelegaldepartmentthrough ResearchNavigator.
  - Initiatere-negotiationprocessifnecessaryduring thetrialperiod.
  - CommunicatewiththeSponsorandOSRforanydeviationsfromthe contracts during the trial period.
  - Ensurebillingcomplianceis maintainedaccordingtobest practices.
  - Facilitatepatient/subject paymentsfortrialparticipation.

- RegulatorySubmissionandMaintenance
  - Createandmaintainregulatorybindersandpatient/subjectbinders.
  - SubmitIRBinitial,continuation,amendment,andstudyclosure applications.
  - Create,maintainandsubmitadverseeventreportsandsafetyreportsto IRB.
  - SubmitandmaintainstudyrelateddocumentsasrequiredbytheSponsor.
  - SubmitFDAapplications,annualsummaryandadverseeventsreports when applicable.
  - StudyConduct and Coordination
    - Implementationofallclinicaltrialphases:
      - Review all elements of the screening process with the Principal Investigator that being: inclusion/exclusion criteria, completed informedconsent,documentationoftheeventandthepatient/subject willingness to participate in the study.
      - Assist with the informed consent process and ensure that the patient/subjectfullyunderstandswhatisrequiredofthemthroughout the study.
      - Scheduleandconductstudyvisits,obtainanddocumentinformation within the time frame specified.
      - Collaboratewithotherdepartmentsthroughoutthe study.
      - Ensureinvestigationaldrugaccountabilityandproperstoring, handling, and dispensation.
      - Collect,prepare,ship,and/orstorebiologicalmaterialsusing universal precautions.
      - Provide reports to all necessary parties (e.g., the Principal Investigator,sponsoringagency,etc.)ontheprogressofthestudyas needed.Ensure successful recruitment and retention of study patients.
      - Ensuresuccessfulstudyclose-out.
    - EnsurestudyteampersonneladheretoGoodClinicalPracticeand compliance with NYUSoM and external regulatory agencies.
    - Providetrainingtostudy teammemberswhen applicable.
    - Study Inspections/Audits
    - Facilitateand ensuresuccessfulinternalinspectionsandaudits.
    - Facilitateand ensuresuccessfulFDAinspectionsandaudits.
    - Facilitateand ensuresuccessful IRBQAinspectionsandaudits.
ReportingandAnalysis

Collaborate with clinical staff in ensure proper review of data, clarifications,interpretationandanalysisforpublicationsifrequestedby Principal Investigator.
Researches, compiles and consolidates data and conducts preliminary analyzestodatacollectedforpresentationtosponsoringandregulatory agencies if requested by Principal Investigator.
Providesreportstoallnecessaryparties(e.g.,theprincipalinvestigator, sponsoring agency, etc.) on the progress of the study as needed.
GeneratespreliminarymeasurementreportsforreviewbyPrincipal Investigator.

ClinicalStaff Goal Management

Overseeandprepareallnecessarydatareportsneededforclinicianmetrics asit relates to research.
Coordinatesandconductsmonthlyresearch 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, pleaseclick here. Pleaseclick hereto view the Federal “EEO is the law” poster or visithttps://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htmfor 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, pleaseclick 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.

Required Skills

Required Experience

Source : NYU Langone