HERC: Metro New York & Southern Connecticut Study Coordinator in Bronx, New York
Employer Name: Albert Einstein College of Medicine
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. Details: 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, oversee verification of patient eligibility and completion of 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 Committees 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 groups 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.