4 weeks ago(9/17/2019 10:38 AM)
- 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, 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 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 Committee’s monthly patient reviews. Perform Cross-Audits of other disease groups and departments.
- 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.
- Coordination of conferences, responsible for organization and participation in bi-institutional real time communication through audio/video conferencing as well as assisting in the development of conferences sponsored by the institution in drug development.
- 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.
- Responsible for providing data for PowerPoint presentations and have ability to collect accrual statistics from the protocol and clinical trials office and tumor registry.
- Report progress on clinical trials at weekly meetings.
- 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.
- Enhanced Regulatory Responsibilities: Actively involved in feasibility questionnaire completion, clinicaltrials.gov submissions for new institutional studies, and new protocol and amendment submissions.
- Trained in various electronic data capture systems and databases. Ability to navigate between systems seamlessly. Expected to train new staff on these systems.
- Key coordination surrounding medical oncology group’s 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.
- Facilitate and oversee all activities associated with planning, development, implementation, monitoring and termination of clinical research studies.
- 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 the collection, recording and maintenance of all data collected for research protocols.
- 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.
- Education requirements for the position: Bachelor's Degree
- Experience requirements for the position: 2-3 years
- 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.
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.