Responsible for all data and reporting for patients enrolled on clinical trials; analysis of data to ensure compliance and accurate reporting to external agencies.
Responsible for ensuring compliance of patients to protocol, verify patient eligibility, oversee the completion of patient consent forms along with physician, patient registration through the Cancer Center Protocol Office, and perform protocol specified procedures that are part of the research project.
Individual will work closely with research team (including Program Leaders, co-investigators, research coordinators, research nurses, other data managers, protocol office staff) in the management of each patient that is accrued to a study. Individual will be responsible for patient study calendars, facilitating patient accrual, oversight and administration of database for central record-keeping; interface with clinical trials office to incorporate latest patient enrollment information in the master system.
Ability to prepare reports for PI for meetings, presentations, abstracts.
Responsible for 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.
Prepare for and participate in internal audit committee of clinical studies as well as external audits by federal agencies and pharmaceutical companies.
Responsible for performing regular self-QA of data and regulatory binder and participating in the Audit Committees monthly patient reviews. Perform Cross-Audits of other disease groups and departments.
Manage the collection of data from importable and exportable formats for rapid dissemination to involved investigators and sponsors. This requires knowledge of ACII databases, excel and access databases as well as some basic knowledge of statistics and statistical packages like SPSS professional.
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.
Report progress on clinical trials at weekly meetings
Assist and ensure all the trial start-up, trial institutional goal accruals and trial close-out activities are met as per the institutional standards.
Discuss with the treating physicians and recommend on the available trial options for a patient that may have exhausted all standard treatment options.
Key coordination surrounding medical oncology groups processing and shipping of Bio Hazards and infectious Bloods at the Moses Campus. Liaison with other departments in facilitating preparation, storage, and shipment of dangerous goods. Appropriate training in handling and shipping is required biannually.
Ability to manage a large number of clinical research studies of different phases, targeting various populations and diseases, and ensuring compliance is maintained overall.
Serve as resource for entire medical oncology clinical research portfolio. Clinicians and team members seek trial information from this resource.
Assist with clinical research training and instruction for investigator and research staff.
Serve as a liaison between principal investigator, external sponsors, and contract research organizations.
Communicate research participant issues promptly and effectively to the regulatory office.
Assist with collection of regulatory documents for research studies.
Participation in study related meetings. Occasional travel may be required.
Maintain clinical competence through continuing education including BLS, ACLS and HIPAA training.
Internal Number: 2019-11803
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.