NYU Winthrop is a 591-bed university-affiliated medical center, which offers sophisticated diagnostic and therapeutic care in virtually every specialty and subspecialty of medicine and surgery. We are a major regional healthcare resource with a deep commitment to medical education and research, offering a full complement of inpatient and outpatient services.
We have an exciting opportunity to join our team as a Mgr, Clinical Trials – Cancer.
In this role, the successful candidate Manages and oversees day to day coordination of all assigned clinical trials, development and study design of new projects relating to clinical research activities within the division. Accountable for the management of clinical trials at the institution and external participating sites per study protocol and within Food and Drug Administration (FDA) /Good Clinical Practice (GCP) /International Conference (ICH) onHarmonisation regulations. Trains and educates new staff. Establishes and maintains research program standards and directs and facilitates work performance of research staff. Travel as necessary.
- Performs other duties as assigned
- Attends various coordinator meetings, traveling time required and overnight stay in some cases. Attends various education lecturers, and other related activities.
- Works with Clinical physician leadership to develop and implement strategies to build and grow the clinical the trials program and research portfolio.
- Communicates and collaborates with grant accounting department and financial Manager clinical trials to ensure finances for all clinical trials are accurate and that payments are received in a timely manner.
- Responsible for oversight of data entry into various programs supported by sponsors and timely completion of Case Report Forms, clear and concise documentation of source documents to support data.
- Responsible for compliance with sponsors requirement throughout the study duration, working with sponsors, medical monitors and other personnel who are instrumental during and upon completion of studies.
- Provides leadership guidance to research coordinator. Manages other clinical trials staff membersand or administrative support for completing of timeliness set forth per protocol. Orients new staff to department and completes annual evaluations of staff.
- Provides oversight for all aspects of clinical trials research protocols. Manages trials from pharmaceutical, cooperative as well as investigator run trials. Ensures compliance will all FDAGCP and all Policies and procedures.
To qualify you must have a Bachelor’s Degree Nursing. Current and valid New York State Registered Professional Nurse license. 3 – 5 years Progressive experience as clinical research coordinator in an academic medical center. Excellent communication (both oral and written), interpersonal, analytical, multitasking, detail orientation, leadership, and organizational skills. Proficient computer skills in MS Office and database applications. Ability to foster smooth communications and teamwork among clinical research faculty and staff as well as external organizations. Knowledge of IRB procedures through all phases of study development..
Required Licenses: Council of Clin Research Coord, Registered Nurse License-NYS
Master’s Degree Nursing,Health Care Administration or PublicHealth. OCN, Oncology Nursing Certification. 1 – 2 years Management or supervisory.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Winthrop 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 Winthrop 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 Winthrop’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.