Study Coordinator - Albert Einstein College of Medicine
Einstein/Resnick - Bronx, NY 10461
About the Job
The candidate recruited to this position will manage the research project activities of NCI studies, pharmaceutical studies and investigator-initiated studies conducted in the Department of Radiation Oncology.
They will be responsible for ensuring the quality and integrity of data collection, assisting the Principal Investigator with the development of the study. Additionally, the candidate may supervise professional and support staff, reviewing work product to ensure study protocol is followed as written and approved by the institution’s IRB.
Details:
- 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.
- 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.
- 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.
- Adherence to all IRB policies, Good Clinical Practice, ICH and FDA guidelines.
- Trained in various electronic data capture systems and databases. Ability to navigate between systems seamlessly. Expected to train new staff on these systems.
- Serve as a liaison between principal investigator, external sponsors, and contract research organizations.
- Education requirements for the position: Bachelor's Degree
- Experience requirements for the position: 1-2 years preferred
- 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
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.