Required: * Associates Degree * 3 years of Clinical Research Experience * BLS
Preferred: * Bachelors Degree * SoCRA or ACRP Certification * Phlebotomy Certified * Medical Assistant Diploma * Experience with Oncology setting
Primary Duties and Responsibilities * Establishes and executes logistical aspects of clinical research projects to achieve project objectives including project planning projecting resource requirements and developing systems to ensure protocol compliance and patient safety. * Coordinates administrative functions of research studies including scheduling of patients for research visits procedures and labs and completion and maintenance of consent forms case report forms SAEs and source documents. * Responsible for screening and recruitment of potential patients for protocol eligibility presenting nonmedical trial concepts and details to the patients and supporting the informed consent process. * Responsible for accurate and timely data collection documentation entry and reporting including resolution of queries from sponsors or regulatory entities. * Coordinates institutional pharmaceutical and internal audits including facilitating third party study monitoring and designs and implements needed corrective actions. * Responsible for compiling and reporting on each study including information related to protocol activity accrual data workload and other research information; present this information at regular research staff meetings. * Responsible for timely submission of adverse events serious adverse events protocol deviations and Safety Letters in accordance with local and federal guidelines. * Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality. * Plans and coordinates strategies for increasing research participant enrollment and/or improving clinical research efficiency as needed. * Provides technical support for the preparation of grant proposals publications presentations and special projects. * Provides assistance with research project budget development including identifying and classifying routine care vs. research related care and provides assistance with research participant research billing and reconciliation. * Attend meetings and conferences related to research activities including research staff meetings. * Participate in planning workshops evaluation meetings and seminars educational or administrative meetings as necessary or requested; Participates in training and education of new research personnel.
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