Clinical Research Operations Manager *Must have a NYS RN License

Mount Sinai Medical Center

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__LinkedIn_

POSITION SUMMARY:

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

Under general supervision from the PI, the Clinical Operations Manager/Research Nurse will be responsible for overseeing the clinical implementation and conduct of an NIH funded Clinical Trial. The NIH study is a large-scale, phase II clinical trial investigating the efficacy of convalescent plasma in hospitalized patients with COVID-19. The clinical trial goal is to enroll up to 1000 patients, across five (5) or more centers nationally (CONTAIN) and obtain data from at least five (5) international centers (COMPILE).

JOB RESPONSIBILITIES:

  • The Clinical Research Operations Manager/Research Nurse will lead a team of research nurses for this project; serve as primary contact and liaison with the PI, Sr. Project Manager, Hospital staff, and DoM Program Director, Research. The Clinical Research Operations Manager/Research Nurse will effectively manage scope, schedule/timelines, quality and resources.
  • Closely collaborate with the PI and Sr. Project Manager in monitoring all study related activities and timelines
  • Train and supervise research nursing staff
  • Ensure adequate research nursing staffing; identify when additional research nursing staff will need to be scheduled for peak periods
  • In collaboration with the PI, conduct the process of assuring adequate informed consent
  • Coordinate study enrollment, including randomization, blood bank communication and lab orders
  • Provide comprehensive nursing care to study participants in the clinical research environment, including participant followup and transportation scheduling
  • Screen daily patient lists for eligibility, be available to consent at each site during low peak periods; , consent LAR remotely, start EPIC chats, re-consent when required, assist with TrialMaster CRFs and CRMS data entry, including WHO score calculations

In collaboration with the PI, manage and report SAEs to the IRB and Sponsor

  • Establish communication with other health professionals within NYU to promote and implement the research study
  • Assure proper GCP training and performance of all team members
  • Ensure that Federal, State, and SoM regulations/guidelines/ SOPs are followed. Ensure that all study related documentation is conducted per SOM/Hospital/Practice policy
  • Provide support across sites for CONTAIN and ensure adequate utilization and productivity of RN staff
  • During down time, collaborate and assist the ACTIV IV team

MINIMUM QUALIFICATIONS:

  • To qualify you must have a NYS RN License with current registration.
  • Graduate of an accredited nursing program.
  • Bachelor's Degree in Nursing or higher.
  • Prior experience in a clinical research setting required.
  • Minimum of 3 years progressively responsible research experience coordinating clinical/research trials and studies.
  • RN, NP, or greater clinician training, with outstanding clinical research skills and experience. Outstanding interpersonal skills.
  • Clinical trials management experience, at least 3 years.
  • Supervisory experience, at least 1 year. Outstanding organizational skills.

PREFERRED QUALIFICATIONS:

Proficiency in using various Microsoft Office applications such as World, Excel, Power Point and Outlook. Familiar with Internet applications, EPIC, TrialMaster, REDCap, CRMS. Effective verbal and written communication skills, strong analytical, organizational and interpersonal skills. Ability to interface effectively with all levels of management and work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Commitment to continuous learning as required by department administration. Ability to make decisions independently. Ability to manage time, multi task and prioritize work. Ability to identify, analyze and solve problems; ability to work well under pressure. Ability to supervise others and help them be successful in their work tasks.

_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. To view the Pay Transparency Notice, please click here [

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