Research - Laboratory/Non-Laboratory, Research Support - Laboratory/Non-Laboratory, Staff/Administrative
Provide leadership for the Division of Pediatric Genetic Medicines research program on the Moses campus. The position will focus on coordination of clinical operations site management and monitoring activities required to initiate, monitor and complete clinical programs at the clinical trial site level.
Supervise the daily activities of the research project(s) with investigators, consultants, data managers, study coordinators, etc;
Mentor and supervise study coordinators, student researchers, and volunteers;
Responsible for managing all Institutional Review Board (IRB)-related activities;
Oversee adherence to research protocols in obtaining informed consent, sample acquisition and testing, data collection and management and participant confidentiality;
Responsible for ensuring the timely submission of case report forms, reporting of adverse events, etc. to appropriate internal departments and external agencies and follow-up with these groups to ensure that all files are complete;
Supervise participant recruitment, tracking, and follow-up;
Responsible for overseeing and managing 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;
Prepare for and participate in internal audit committee of clinical studies as well as external audits by federal agencies and pharmaceutical companies;
Maintain records of study incentives, subject honoraria, and travel reimbursements; facilitate other study-related financial transactions;
Work with PI and research team to refine and finalize research protocols, assist with creation of standard operating study procedures when needed, draft study questionnaires and data collection tools;
Assist Investigators in writing, preparing and submitting grant applications and manuscripts;
Provide regular data reports to investigator and assist with preparation of annual reports;
Independently oversee all aspects of project implementation, including expense reviews, regulatory, personnel, and data management;
Facilitate the preparation of conference abstracts, oral presentations, and poster presentations, and participate in the development of manuscripts for publication;
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;
Work with Program Manager to develop and monitor trial budgets and contracts.
Will communicate and coordinate with the Principal Investigator and Research Program Manager.
Will provide effective recommendations in the management and oversight of research study staff.
May liaise with study participants and interact with research staff on a daily basis.Acts independently in protocol lead role and to determine methods and procedures on new assignments. Specifically:
Uses operational and therapeutic expertise to optimize clinical trial design and execution.
Implements clinical trial tools and mechanisms to facilitate the completion of research goals.
Works with the study team and other members of the clinical staff to design clinical trial protocols consistent with the clinical development plan.
Develops routine data review plan to ensure study objectives are met and are being adequately captured.
Prepares study-related documentation for dissemination to institutional review boards, overseeing committees, and multi-center institutions.
Provides input for the design of the ICF template, CRFs, monitoring conventions, edit checks, etc.
Assists clinical research coordinators and other research staff members in the timely and accurate completion of data and reports.
Coaches and provides guidance to clinical staff.
Coordinates and leads disease specific research meetings and provides updates on clinical trial affairs with clinical research staff including: principal investigators, co-investigators, managers, and coordinators.
Internal Number: 2021-13472
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.