Study Coordinator
Albert Einstein College of Medicine, Inc
 SoHo, NY






  • Study Coordinator






    Job ID

    2019-12337



    Campus


    Einstein/Resnick - Bronx


    Posting Date

    2 weeks ago(10/2/2019 9:07 AM)


    Employee Classification

    Non-Exempt/Non-Union


    Department

    Cancer Center


    Position Type

    Regular Full-Time









  • POSITION RESPONSIBILITIES




    • 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






    QUALIFICATIONS




    • Bachelor’s Degree and 1-3 years of related experience.

    • Master’s Degree strongly preferred.

    • Clinical trials certification by SOCRA preferred. Or achieved within first 2 years of employment

    Skills and Competencies 


    • Must be proficient in Microsoft Office and have the ability to apply technology to resolve problems.

    • Must demonstrate proven knowledge of SPSS, SAS, or other statistical software and ability to perform data analysis.

    • Outstanding judgment, initiative, and attention to detail are essential. Must be able manage competing priorities while supporting more than one PI.

    • Can be relied upon to ensure that activities within areas of specific responsibility are completed in a timely manner and within budget

    • Outline project goals and timelines and reviews progress at defined intervals.

    • Ability to work well in a team setting and independently is essential.

    • Speaks clearly and expresses self well in one-on-one conversations and groups

    • Develops effective written communications and uses them appropriately






    ABOUT US




    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.



    We have also been recognized by Forbes as one of the country's best midsize employers in 2019. Forbes ranked Einstein in the top overall nationally among midsize employers. Einstein ranked 3rd within the education category in New York State and 9th nationally among all midsize education employers.



    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 Phase I Study Coordinator manages the quality and integrity of data collection. May also assist Principal Investigator with the development of the study. Works closely with PI and Phase I manager.  Reviewing  work product to ensure study protocol is followed as written and approved by the institution’s IRB.