A sample of typical duties for this position includes:
- Clinical Supervision and Assessment
- Clinically supervise any physicians or nurses in training conducting clinical research procedures.
- Complete clinical assessments, including physical exams, dose adjustments and medical histories, for subjects enrolled in clinical trials.
- Regulatory Management of Clinical Trials
- Ensure the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations and Institutional Review Board (IRB) approvals.
- Oversee IRB submissions and reporting to Montefiore-Einstein IRB and/or BRANY IRB
- Maintain central regulatory files and regulatory document processing
- IND Preparation, Documentation and Reporting
- Other related duties as assigned.
- Certified and registered as a nurse practitioner (NP) by the New York State Education Department (NYSED) in order to practice as an NP in New York.
- At least 2 years of past experience in clinical research is required.
- A familiarity of psychological and psychiatric research design and subject matter is preferable.
- A commitment of at least 2 years is required.
- Knowledge of medical terminology, clinical medicine, clinical trials and Good Clinical Practice concepts.
- Nursing competency skills per scope of practice.
- Knowledge of GCP, federal, state and local regulations, including HIPPA policies and procedures.
- Must be extremely organized, detail oriented and technologically knowledgeable.
- Must have advanced problem solving and analytical skills, with the ability to regularly prioritize.
- Must be able to multi task and focus on numerous projects at once. Efficient time management is imperative as meeting the deadlines for grants, fiscal and regulatory submissions is constant.
- Ability to work independently and in a team environment.
- Must have a professional demeanor and strong communication skills.
- Knowledge and understanding of the unique patient population that we work with and sensitivity toward their specific needs and issues.
Founded in 1955, the Albert Einstein College of Medicine (Einstein) is one of the nation’s premier institutions for medical education, basic research and clinical investigation. A full-time faculty of some 2,000 conducts research, teaches, and delivers health care in every major biomedical specialty. The college has some 730 medical students, 193 Ph.D. students, 106 MD/Ph.D. students and 275 postdoctoral fellows.
Einstein’s major strength, in addition to training physicians and scientists, is its science. During fiscal year 2015, the faculty’s consistently high level of scientific achievement resulted in the awarding of more than $150 million in peer-reviewed grants from the National Institutes of Health (NIH).
Einstein is part of Montefiore Medicine Academic Health System, an integrated academic delivery system comprising seven campuses, including 8 hospitals, a multi-county ambulatory network, a new state-of-the art “hospital without beds”, a skilled nursing facility, school of nursing, home health agency, and the state’s first freestanding emergency department. As the University Hospital for the Albert Einstein College of Medicine, Montefiore is a premier academic health system, employing Einstein’s clinical faculty and training Einstein’s medical students, over 1,300 residents, 420 allied health students, and 1,600 nursing students annually.
We have also been recognized by Forbes as one of the country's best midsize employers in 2019. Forbes ranked Einstein in the top overall nationally among midsize employers. Einstein ranked 3rd within the education category in New York State and 9th nationally among all midsize education employers.
The Albert Einstein College of Medicine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Einstein seeks candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence, and the communities we serve.
The Clinical Research Nurse Practitioner, under the guidance and supervision of the Principal Investigator, Dr. Eric Hollander, provides operational oversight to the study team, regulatory and financial management of federal, industry-sponsored and investigator-initiated studies, and clinical supervision to site personnel.