• Research Coordinator

    Posting Date 4 months ago(3/9/2018 9:50 AM)
    Job ID
    Einstein/Resnick - Bronx
    Employee Classification
    Cancer Center
    Position Type
    Regular Full-Time

    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 person recruited for this position is responsible for the coordination of data management and data retrieval and analysis for CTEP-sponsored NCI studies, pharmaceutical studies and investigator-initiated studies conducted at the Einstein Cancer Center/Montefiore Medical Center.


    • Responsible for all data and reporting for patients enrolled on clinical trials; analysis of data to ensure compliance and accurate reporting to external
    • Responsible for ensuring compliance of patients to protocol, verify patient eligibility, complete 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
    • Ability to prepare reports for PI for meetings, presentations
    • Responsible for the timely submission of case report forms, reporting of adverse events, to appropriate internal departments and external agencies and follow-up with these groups to ensure that all files are complete.
    • Responsible for performing regular self QA of data and patient binders.
    • 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, 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, 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.
    • Maintain patient and protocol confidentiality. Ability to handle patient interactions professionally, possessing strong interpersonal skills.
    • Ongoing demonstration of commitment to team cohesiveness and growth.
    • Possess sound knowledge of Good Clinical Practice and local and federal policies and regulations. Serves as a resource to team, clinicians, and other clinical research professionals in meeting requirements of GCP, research ethics, and regulations.
    • Trained in various electronic data capture systems and databases. Ability to navigate between systems seamlessly.
    • Assist and ensure all the trial start-up, trial institutional goal accruals and trial close-out activities are met as per the institutional
    • Discuss with the treating physicians and recommend on the available trial options for a patient that may have exhausted all standard treatment
    • Key coordination surrounding medical oncology group’s processing and shipping of Bio Hazards and infectious Bloods 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
    • Serve as resource for entire medical oncology clinical research portfolio. Clinicians and team members seek trial information from this
    • Review and evaluate all new protocols to determine the feasibility of conducting the study. Assist regulatory coordinators with feasibility questionnaires and determination of potential compliance risks of new studies based on knowledge of patient population and institutional
    • Facilitate and oversee all activities associated with planning, development, implementation, monitoring and termination of clinical research studies.
    • Assist in resolving clinical and operational
    • Serve as a liaison between principal investigator, external sponsors, and contract research organizations.
    • Coordinate and organize the administrative activities for the pre-study assessments, study initiation visits, and monitoring visits with the sponsors or contract research organizations.
    • Supervise appropriate and safe research participant management according to
    • Supervise the collection, recording and maintenance of all data collected for research protocols.
    • Communicate research participant issues promptly and effectively to the regulatory of
    • Assist with collection of regulatory documents for research studies.
    • Participation in study related Occasional travel may be required.
    • Maintain clinical competence through continuing education including BLS, ACLS and HIPAA
    • Adherence to all IRB policies, Good Clinical Practice, ICH and FDA


    • Education requirements for the position: Bachelor's Degree
    • Experience requirements for the position: 3-5 rears of related exeperience
    • Certifications, license or special trainings: Though not a requirement for this position, it would be an asset to the program if a candidate could be identified who has had prior experience working in clinical trials data management in either an academic or pharmaceutical setting and who understands the dynamics of such a position. Educational background that would be extremely beneficial includes clinical trials certification by SOCRA or other courses that provide this training.


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