The Clinical Studies Coordinator collaborates with the research team and principal investigator to coordinate the institutional and federal approval procedures for research lab and clinical trials as well as develop and maintain a thorough tracking system for all department lab protocols. Provides effective coordination and administrative support for the GU Tissue Core. Functions in a separate and independent manner in the design and initiation of research data management. Designs, develops or adapts data management tools to obtain desired results. Compiles, writes and submits project results to superiors.
• Responsible for the organization, tracking, scheduling, and completion of GU tissue-based projects. Collaborates with members of the Tissue Core to coordinate work-flow and develops new systems to maximize efficiency. Presents project data to oversight committee.
• Responsible for ensuring that all biospecimen requests are compliant with relevant policies, procedures, and regulations. Interacts with the IRB and other regulatory bodies to keep abreast with current requirements. Verifies protocol consent status and authorization of use of data and biospecimens by following institutional guidelines. Develops and updates department process flow charts and guidelines. Teaches and monitors authorized staff in verification process. Verifies authorization and approval of testing as indicated in the IRB approved protocol.
• Serves as a liaison between investigators, GU Tissue Core, GU Tissue Core Oversight Committee, and other key stakeholders. Collaborates with groups to develop shared resources. Organizes and leads team meetings. Develops an action plan to reach goals within a specified time period. Delegates specific tasks within the team, monitors and assists team members in reaching goals within that time.
• Discusses and assist principal investigators with material transfer agreements (MTA). Develops and maintains a tracking data base of MTA status. Trains authorized staff on how to assist principal investigator with MTA. Produces flowcharts and guidelines on process.
• Coordination of the timely protocol preparation, review, and submission for new and amended protocol documents for the Institutional Review Board (IRB), the National Cancer Institute (NCI), the Food and Drug Administration (FDA), and other approving committees.
• Efficient collaboration with physicians, research nurse supervisor(s), laboratory manager, and other personnel to ensure that deadlines are met and all protocols are properly formatted, contain appropriate related documents and appendices, and have no typographical or grammatical errors (investigator-initiated protocols) before initial submission to approving committees.
• Quality Assurance to ensure consistency between protocol and related financial documents and that the protocols are written in accordance with institutional and federal guidelines governing clinical research and lab protocols.
• Collaboration with industry sponsors and supporters as necessary to ensure compliance with private industry operating procedures relating to protocol document language
• Abstract and informed consent composition for new protocols, as well as informed consent revisions and submissions to IRB and NCI, (if applicable) based on adverse event data.
• Appropriate communication and timely responses to internal reviewers and external agencies (pharmaceutical companies, government sponsors, etc).
• Maintenance of written reports tracking all clinical research and lab protocols throughout the submission/revision process, to include daily or weekly progress reports to relevant research team staff and monthly maintenance and distribution of a complete departmental protocol list.
• Completion of forms (as specified) for protocol, contract, and budget approval and activation.
• Create, update,
Texas Nurses Association - 19 months ago