Research Coordinator 2 - Division of Cardiology, Department of Medicine at UW in Seattle, WA

Job description

Job Description The University of Washington, Division of Cardiology has an outstanding opportunity for a full-time Research Coordinator. About this Opportunity: Reporting to the Clinical Research Manager, the Research Coordinator works with Division of Cardiology faculty to facilitate investigator-initiated and industry sponsor drug and device clinical trials. The purpose of this position is to promote the research objectives of the Clinical Trials Unit (CTU). This position is responsible for implementing multiple research projects in human subjects. This position will utilize operational knowledge of the University of Washington, a firm understanding of the clinical research process, and an ability to integrate this knowledge with research priorities to implement program goals. Key Responsibilities: This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position requires daily interaction with industry sponsors (pharmaceutical and device), physicians, and other healthcare personnel (nurses, patient care coordinators, etc), and patients. Up to 10 projects will progress simultaneously with an expectation of additional projects in the future. Protocol Management - 40% · With minimal guidance implement research project procedures that meet research objectives and ensure compliance with all aspects of Institution and federal regulations. This position will be responsible for all aspects of multiple clinical trials, including patient recruitment and management, study data collection and management, and study administration. · Develop, document, and maintain procedures for patient registration and activities, and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines. · Coordinate and conduct study visits and activities, record and collect study data, complete data entry, maintain study source records, and resolve queries based on source documentation. · Work with Regulatory Coordinator to develop and implement study tools and source documents, maintain regulatory documents, and review and complete regulatory submissions to Institutional Review Boards and other regulatory and reviewing boards. · Work collaboratively with the research team (regulatory coordinator, research assistants) to ensure that projects are executed successfully and completed within the required time frames to meet research objectives and metrics. Data & Patient Management – 40% · Responsible for facilitating and tracking study visits, tests, and procedures in accordance with the protocol, ensuring billing compliance, and accurate and complete data collection, including informed consent forms and source documentation. · Obtain, abstract, and code clinical information from multiple sources (medical records, research records, etc) for research participants in order to enter data into study specific data capture systems, and to document, assess, and report adverse events and safety data to study investigators, sponsors, IRB’s and other regulatory authorities when applicable. · Work with monitors and sponsors to facility study site visits, and, and with limited guidance to develop and implement corrective action plans to ensure protocol adherence, and data integrity, and to resolve queries in a timely manner. Communication & Administration – 20% · A good working knowledge of each protocol, and familiarity with patient populations, diseases, and clinical service line operations necessary to manage assigned study portfolio. · Effective and timely communication with industry sponsors and sponsor affiliates, physicians, clinical service lines, and patients is an essential part of this position. · This position will independently manage multiple projects simultaneously, routinely work under specific timelines or deadlines, with specific timelines or to meet deadlines, and often may require a high degree of prioritization and adaptability. Required Qualifi