With the Phase I leadership at the Moses and MMP campuses for the Phase 1 program The position will focus on the data collection of all clinical phase I program and monitoring activities required to initiate, monitor and complete clinical programs at the clinical trial site level
Work with PI to develop the study protocol and protocol amendments for the IRB as needed, including the development of new measures.
Manage data collection, analysis and cleaning, performing regular audits to ensure that the data collected are complete and accurate, and that the research is being conducted as outlined in the protocol.
Develop appropriate progress reports for the PI, study funding agency and the IRB.
Assist PI with preparation of grant proposals (new and competing renewals).
Arrange meetings of study partners, develop meeting agendas, and facilitate meeting.
Facilitate the preparation of conference abstracts, oral presentations, and poster presentations, and participate in the development of manuscripts for publication.
Partner with departmental IT resources in the development of databases; data coding manuals and data entry guidelines. Train staff and interns to collect and enter data appropriately.
Manage the collection of data from importable and exportable formats for rapid dissemination to PIs and sponsors.
Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed.
Ensure that adverse events and protocol deviations are submitted to the IRB.
Represent the study at internal and external academic meetings and community events. Act as a liaison to project partners to discuss new procedures that could be implemented.
Determine staffing needs to ensure efficient and appropriate coverage, and recommend appropriate changes to staffing patterns as needed. Manage staff performance and valuate the quality of work providing timely and corrective feedback as needed.
Recruit, acclimate, and supervise undergraduate and graduate student research interns.
Work with Departmental Administrator to develop and monitor project budgets
Prepare for and participate in internal audit committee of clinical studies as well as external audits by federal agencies and pharmaceutical companies
Participation in conference calls with NCI, the sponsor and other agencies in the conduct of studies, patients accrual and dissemination of data verbally for purposes of communicating toxicities, AEs, etc. to all collaborators.
Responsible for providing data for powerpoint presentations and have ability to collect accrual statistics from the protocol and clinical trials office and tumor registry
This individual will also participate in meetings with other data managers to discuss new procedures that should be implemented for the management of data and will attend meetings with pharmaceutical companies, government agencies, etc. when protocols commence. They will also be responsible for meeting with representatives as part of the site initiation for a new study
Report progress on clinical trials at weekly meetings and keep log of same.
Maintain a log of all adverse events that are experienced by patients while on a trial.
Travel up to 10% to site investigative meetings
Internal Number: 2019-12337
About Albert Einstein College of Medicine
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, e...mploying 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.