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.
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 Manager for Clinical Research Implementation Services functions in a complementary fashion with institutional offices to facilitate the conduct and efficiency of research involving human subjects. The Manager for Clinical Research Implementation Services is a resource to investigators and research staff on research subject safety, monitoring, quality, and implementation of Good Clinical Practice (GCP). S/he works in accordance with the policies of the Albert Einstein College of Medicine, Montefiore Medical Center, and the College of Medicine on regulatory compliance and achievement of the goals and objectives related to clinical research processes and implementation.
- Find, evaluate and bring to College of Medicine and Montefiore Medical Center tools and skills to facilitate clinical trials and clinical research.
- Facilitate and lead institutional movement into informatics-based recruitment for clinical trials.
- Facilitate and lead institutional movement into employed social media in clinical research.
- Serve as a resource for investigators and coordinators in activating and implementing clinical research at both campuses.
- Act as the institutional liaison with the national CTSA Consortium and Trial Innovation Network in matters related to clinical trials, recruitment, and investigator engagement.
- Serve as the liaison with the national Patient-Centered Clinical Research Network (PCORnet), and the New York City Clinical Data Research Network (NYC-CDRN), initiatives of the Patient-Centered Outcomes Research Institute (PCORI). This involves staying abreast of collaborative opportunities, assisting in the development of research proposals for submission to PCORI, and assisting investigators with the required resources to support and implement PCORI-approved interventional and observation studies
- Collaborate in the orientation of new investigators and research staff and the ongoing education of research personnel.
- In collaboration with the ICTR Executive Director and Assistant Director of the Office of Clinical Trials develop job descriptions, and assure the recruitment, training and retention of research study coordinators on an as-needed basis.
- Assist and lead investigators in the development of protocols, data safety monitoring plans, IND/IDE applications and annual reporting to the FDA, clinicaltrials.gov, etc.
- Audit (as directed) ongoing clinical studies for protocol compliance, eligibility criteria, serious adverse events, and CRF documentation as per protocol.
- Identify service improvement opportunities that will reduce or eliminate barriers to research as experienced or perceived by research participants.
- Represent the ICTR at national CTSA meetings that cover the above areas of responsibility and relate to CTSA-specific initiatives around these themes. Strengthen local, regional and national networks, and build collaborations around common goals.
Bachelor's degree required, Masters degree preferred, preferably in a health related and/or research field, and some clinical research management experience.
S/he must be able to interact well with internal and external stakeholders who may have conflicting priorities and needs.
This position requires a high degree of maturity and the ability to maintain confidentiality of sensitive information, such as compliance issues, medical information, and programmatic issues.
Influences the behavior of others through effective communication. Excellent written and verbal communication is required.
Seeks input, meets expectations and maintains communication with the client.
Recognizes strategic opportunities to enhance success.
Employee Classification: Exempt