Full Time
New York
Posted 2 weeks ago

ABOUT NYU LANGONE HEALTH

NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. It comprises more than 200 locations throughout the New York area, including six inpatient locationsa children’s hospitalthree emergency rooms and a level 1 trauma center. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute designated comprehensive cancer center, and NYU Grossman School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history.

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.

With over six inpatient locations, and additional facilities spread throughout, NYU Langone Health is New York City’s premier healthcare institution. Our world-class facilities service all five boroughs and treat a full range of medical conditions in both inpatient and outpatient settings. Our growing outpatient network allows us to deliver our exceptional medical services directly to the communities we serve. Plus, our doctors and nurses are routinely voted as some of the best in the nation. It’s no wonder why the name NYU Langone Health has become synonymous with excellence.

Job Details

We have an exciting opportunity to join our team as a Research Project Manager.

The Research Project Manager will independently manage and execute all aspects on a number of private, federal, and industry-funded studies in the PTSD and Addiction Research Program.

He/She will work closely with the Principal Investigators to see research projects through from start to finish while ensuring compliance and scientific integrity. The Research Project Manager is responsible for ensuring that studies are carried out in accordance with institutional, state, and federal regulations and standard operating procedures, and is accountable for the day-to-day operations, finances, and execution of clinical trials to ensure the trial activities are conducted per regulatory compliance. The Research Project Manager will provide supervision for research associates, research coordinators and volunteer study staff.

Job Responsibilities:

  • Prepare and submit of reports (annual, progress, financial, safety etc.) to regulatory agencies, federal & state oversight organizations, data & safety monitoring boards and study sponsors.
    Create and maintain study records within all portals of Research Navigator (My Studies, IRB, CRMS, My Agreements, etc.) and Regulatory Binders. Prepare submissions as necessary.
    Maintain FDA INDs held by the Principal Investigators.
    Prepare and submit of applications for PI DEA and BNE Licensure & Registration.
    Assist in protocol development & grant writing as needed.
    Establish and follow Standard Operating Procedures to ensure adherence to trial protocols and administrative requirements.
    Ensure study team personnel adherence to Good Clinical Practice and compliance with NYUSoM and external regulatory agencies.
    Oversee Quality Assurance activities.
    Facilitate agreements in collaboration with SPA as necessary (Consulting, Data Sharing, Biospecimen transfer, etc.).
  • Act as primary point of contact for all trials and manage day-to-day communication and activities of the clinical trial team.
    Meet regularly with the PI to review and monitor the overall conduct of the study.
    Utilize available resources and established procedures in order to rectify problems and communicate all changes.
    Prepare internal and external memos, source document and case report form templates, reports, and correspondence required to properly manage and document activities on the studies.
    Coordinate study-drug shipment, accountability and compounding.
    Handle, collect, prepare, transport and ship biological specimens as required by study protocols.
    Schedule and coordinate study visits as needed.
    Conduct study visits with Research Staff and PI, collect data as required.
  • Manage and maintain all finances associated with all above-mentioned studies & grants.
    Oversee budget planning, resource allocation and preparation of reports delivered to PI.
    Ensure accuracy and timeliness of study consultant and vendor payments as well as study subject reimbursement and compensation payments.
    Maintain and manage petty cash accounts as necessary.
    Reconcile grant accounts on a regular basis to ensure that expenditures and revenues are within appropriate limits and guidelines.
    Ensure that costs are consistent with the project schedule.
    Oversee study materials and supplies & monitoring quantities. Initiates ordering or new supplies with reference to study budgets when necessary.
    Work directly with sponsors to ensure open and accurate communication regarding the study funds.
  • Establish and cultivate relationships with NYU clinical staff including physicians, NPs, social workers, etc. in efforts to recruit patients and maintain positive affiliation.
    Lead the ongoing recruitment efforts at Tisch Hospital, Bellevue Hospital Center and outside sources to ensure subject accrual goals.
    Create and place advertisements in various media platforms so as to expand recruitment efforts to the general population who may be interested in potentially participating in respective research projects.
    Initiate and schedule meetings/presentations/outreach activities between the study staff and medical center staff and treatment demographic population.
    Obtain informed consent, assess for eligibility and coordinate subsequent study visits with enrolled participants.
    Maintain study-specific logs with regards to NYUSOM IRB, NYS and Federal regulations.
  • Oversee creation and management of databases and entry for all studies, ensuring accurate and timely input.
    Coordinate the transfer of database files to technician and statistician for interim data analyses.
    Ensure protocol compliance: standard steps regarding eligibility criteria, follow-up, and required documentation consistently followed in the time frame specified.
    Review and audit data entered by study personnel.
  • Mentor junior staff and volunteer study staff throughout the course of all studies.
    Oversee MyTime time management system for study team members.
    Coordinate promotions and new hire requisitions as needed.
    Onboard and supervise junior staff as needed.
    Work to PI to facilitate study team cohesion and collaboration.
    Delegate to junior staff and volunteers as necessary.

Minimum Qualifications:

To qualify you must have a Bachelors Degree required.

5 years of clinical research project management experience
Computer literacy: proficiency using Microsoft Office applications such as Word, Excel, Power Point and Outlook.
Effective oral, 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
Flexible schedule preferred as night and weekend work may be required pending study enrollment and visit scheduling

Preferred Qualifications:

Masters Degree in behavioral science or related field preferred
Experience working with various mental health populations (Substance use, PTSD, etc.) preferred
Clinical Research Coordinator certification (CRC) 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. To view the Pay Transparency Notice, please click here.

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. For more information, go to med.nyu.edu, and interact with us on LinkedInGlassdoorIndeed,FacebookTwitter and Instagram.

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Research

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