Assist with managing the Clinical Research Management System Quality Assurance Program for Einstein and Montefiore campuses by coordinating clinical operations site management and monitoring activities
Assist with providing mentorship activities and oversight to coordinators at both Einstein and Montefiore campuses in use of the Clinical Trial and Research Management System. Provide Oversee.clinical operations input to the clinical research management system team for the Cancer Centerresearch teams at the Moses Campus and MMP.
Responsible for development of training modules and programs for incoming and current study coordinators and research staff.
Facilitate a variety of evaluation methods to improve medical oncology operations.
Provide feedback and help to implement processes based on findings from ongoing evaluations
Collaborate with other managers on goal setting, development and tracking for the Cancer Center research operations
Use data-driven management strategies to meet research team goals
Create and lead workshops to promote cohesive team operations and adherence to local and national research standards
Conduct and report on performance reviews for AECOM study coordinators and data managers.
Responsible for all metadata 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, (e.g. 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
Independently oversee all aspects of project implementation, including budgetary, personnel, and data management.
Manage clinical trial site monitoring team metrics (e.g. monitoring frequency and trip report completion, CRFs expected/outstanding, Source Document Verification (SDV) progress, query aging, monitoring resource requirements, etc) to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meets clinical trial and corporate goals.
Oversee research specimen collection, including accountability, monitoring, reconciliation, and shipment as needed.
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
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
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 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
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
Generate annual financial reports;
Report progress on clinical trials at weekly meetings
Travel up to 10% to site investigative meetings
Scope of Responsibility
Works on complex and abstract problems where analysis of situations or data requires an evaluation of intangible factors.
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining solutions.
Ensures all clinical trials are executed in compliance with international GCP guidelines/regulations and standard operating procedures.
Participates in the planning of quality assurance activities, coordinates resolution of audit findings, and facilitates the drafting and execution of corrective action plans.
Ensures audit-ready condition of clinical trial documentation including research files; reviews monitoring reports to ensure quality and resolution of site-related issues; coordinates and assists in the planning of regulatory or ethics committee activities, as appropriate.
Leads the study team in preparation for routine audits, research reviews, and DSMC meetings.
Meets frequently with Cancer Services Research Administrator and members of the cross-functional study team to discuss clinical trial details (budgeting, SOC assessments, regulatory affairs, CROs, vendors, etc.)
Collaborates frequently with principal investigators in screening research patients, determining eligibility criteria, and communicating inclusion findings to vendors and regulatory bodies.
Acts independently in protocol operations lead role and to determine methods and procedures on new assignments. Specifically:
Uses operational and/or therapeutic expertise to optimize clinical trial operations design and execution.
Implements clinical trial tools and mechanisms to facilitate the completion of research goals.
Works with the study team and other members of the clinical staff to design clinical trial protocols operations consistent with the clinical development plan.
Develops routine data review plan to ensure study objectives are met and are being adequately captured.
Assesses clinical study tools capture intended study data; generates case report forms that ensure detection of data trends.
Prepares study-related documentation for dissemination to institutional review boards, overseeing committees, and multi-center institutions.
Provides input for the design of the ICF template, CRFs, monitoring conventions, edit checks, etc.
Assists clinical research coordinators and other research staff members in the timely and accurate completion of data and reports.
Provides guidance to clinical staff.
Coordinates and leads disease specific research meetings and provides updates on clinical trial affairs with clinical research staff including: principal investigators, research nurses, PAs, clinical trial coordinators, and administrative staff.
Internal Number: 2020-12839
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.