The Project Manager manages research project activities ensuring the quality and integrity of data collection, recruitment and enrollment of study subjects. This position involves working with hospitalized COVID-19 patients, which will require direct patient contact in our hospital enrollment sites. ROLE IS TEMPORARY FOR ONE YEAR.
Administration & Regulatory
Works with Principal Investigator and study collaborators to develop and update study protocols, including the data collection tools/case report forms
Prepares protocol amendments and submissions to IRB and IND and manages all related approvals
Maintains clinicaltrial.gov registry information and reporting
Maintains regulatory documents including regulatory binders, site approvals,
Arranges conference calls with study collaborators and clinical staff; develops meeting agendas, and records meeting information.
Assists in drafting reports, preparing conference abstracts, and presentations related to the project.
Processes and track all payments to study participants using Greenphire software system
Works with Administrator to ensure budget compliance and invoicing requirements are met
Manage the day-to-day operations of the projects with Principal Investigators and clinical staff
Coordinates study enrollment, protocol treatment, and follow-up visits for patients participating in clinical trial
Works with Principal Investigator and clinical staff to confirm that each patient meets eligibility criteria specified for protocols and enrollment
Manages the collection, preparation, shipment, and storage of biological materials including patient samples and study drug using universal precautions
Assists with the informed consent process and ensure that the patient fully understands what is required throughout the study;
Collects follow-up data on patient post-treatment as required by the protocol and submits monthly reports
Communicates with various internal departments, clinical staff, labs, external collaborators, and all members of the clinical team to ensure accuracy, timely retrieval of data, and confirm that research protocols are being followed
Manages patient tracking database; prepare regular reports for patient follow-up and study-visit completion.
Performs data entry and collection of clinical information and follow-up data from medical records.
Performs regular data audits to ensure that collected data are complete and accurate, and.
Other duties and responsibilities as assigned.
Internal Number: 2020-12773
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.