Veterans Staffing
Senior Clinical Research Coordinator - Internal Medicine (Pulmonary)
Veterans Staffing, Kansas City, Kansas, United States, 66101
Senior Clinical Research Coordinator - Internal Medicine (Pulmonary)
The Senior Clinical Research Coordinator in The Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Kansas Medical Center will be responsible for independently managing and coordinating multiple, complex Phase I-IV industry-sponsored, investigator-initiated, and federally funded clinical trials. This individual will serve as the primary liaison between study sponsors, investigators, and internal research units, ensuring all activities are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, and institutional policies. Job Duties Outlined
Clinical Trial Management: Manage all operational aspects of multiple concurrent clinical trials from start-up through close-out, with minimal oversight. Coordinate and track essential regulatory and study documentation, ensuring readiness for audits and monitoring visits. Create and maintain study binders, source documentation templates, and other regulatory-compliant tools. Participate in Site Selection Visits (SSVs), Site Initiation Visits (SIVs), Monitoring Visits, and Close-Out Visits with study sponsors and CROs. Facilitate protocol feasibility reviews and coordinate site qualification documentation. Serve as the primary liaison with sponsors, CROs, and internal departments. Participant Coordination & Oversight: Conduct prescreening, recruitment, consent, and enrollment activities in collaboration with investigators. Ensure protocol compliance during study visits, including specimen collection, investigational product accountability, and data documentation. Recognize and report adverse events, deviations, and unanticipated problems in a timely manner to the Principal Investigator for review. Assist the Principal Investigator with the documentation and timely reporting of adverse events, protocol deviations, and unanticipated problems to sponsors, CROs, and regulatory authorities, as required by study guidelines and at the direction of the Investigator. Serve as a resource for study participants, answering questions, providing support, and ensuring retention throughout study participation. Regulatory Affairs, Data Management, & Quality Assurance: Prepare and assist with IRB submissions, amendments, continuing reviews, and regulatory binders. Maintain up-to-date and audit-ready regulatory binders and electronic documentation systems (e.g., Complion, REDCap). Conduct periodic self-audits and internal quality reviews to ensure continuous adherence to protocol and SOPs. Lead internal audits and assist with sponsor/CRO monitoring visits, external audits, and FDA inspections. Ensure timely and accurate data entry into Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS), including REDCap, VELOS, and sponsor portals. Reconcile discrepancies between source documentation and EDC queries in collaboration with data management teams. Assist with development and maintenance of source documentation templates and participant tracking logs. Leadership & Mentorship: Serve as a resource and mentor for clinical research coordinators and clinical research assistants. Assist with onboarding and training of new team members. Contribute to process improvement initiatives and standard operating procedures. Administrative & Financial Oversight: Contribute to team meetings, protocol reviews, and quality improvement initiatives. Collaborate with investigators and budget specialists to provide input during the development of the main study budget. Ensure all study-related information in VELOS is accurate and up-to-date to support timely payment processing by the Clinical Trials Finance Office (CT Finance). Respond to and assist CT Finance with sponsor inquiries related to invoicing, payment reconciliation, and financial reporting. Track participant stipends and maintain records of study-related procedures to support billing compliance. Represent the Pulmonary, Critical Care, and Sleep Medicine Research Division in cross-departmental working groups and special projects.
The Senior Clinical Research Coordinator in The Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Kansas Medical Center will be responsible for independently managing and coordinating multiple, complex Phase I-IV industry-sponsored, investigator-initiated, and federally funded clinical trials. This individual will serve as the primary liaison between study sponsors, investigators, and internal research units, ensuring all activities are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, and institutional policies. Job Duties Outlined
Clinical Trial Management: Manage all operational aspects of multiple concurrent clinical trials from start-up through close-out, with minimal oversight. Coordinate and track essential regulatory and study documentation, ensuring readiness for audits and monitoring visits. Create and maintain study binders, source documentation templates, and other regulatory-compliant tools. Participate in Site Selection Visits (SSVs), Site Initiation Visits (SIVs), Monitoring Visits, and Close-Out Visits with study sponsors and CROs. Facilitate protocol feasibility reviews and coordinate site qualification documentation. Serve as the primary liaison with sponsors, CROs, and internal departments. Participant Coordination & Oversight: Conduct prescreening, recruitment, consent, and enrollment activities in collaboration with investigators. Ensure protocol compliance during study visits, including specimen collection, investigational product accountability, and data documentation. Recognize and report adverse events, deviations, and unanticipated problems in a timely manner to the Principal Investigator for review. Assist the Principal Investigator with the documentation and timely reporting of adverse events, protocol deviations, and unanticipated problems to sponsors, CROs, and regulatory authorities, as required by study guidelines and at the direction of the Investigator. Serve as a resource for study participants, answering questions, providing support, and ensuring retention throughout study participation. Regulatory Affairs, Data Management, & Quality Assurance: Prepare and assist with IRB submissions, amendments, continuing reviews, and regulatory binders. Maintain up-to-date and audit-ready regulatory binders and electronic documentation systems (e.g., Complion, REDCap). Conduct periodic self-audits and internal quality reviews to ensure continuous adherence to protocol and SOPs. Lead internal audits and assist with sponsor/CRO monitoring visits, external audits, and FDA inspections. Ensure timely and accurate data entry into Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS), including REDCap, VELOS, and sponsor portals. Reconcile discrepancies between source documentation and EDC queries in collaboration with data management teams. Assist with development and maintenance of source documentation templates and participant tracking logs. Leadership & Mentorship: Serve as a resource and mentor for clinical research coordinators and clinical research assistants. Assist with onboarding and training of new team members. Contribute to process improvement initiatives and standard operating procedures. Administrative & Financial Oversight: Contribute to team meetings, protocol reviews, and quality improvement initiatives. Collaborate with investigators and budget specialists to provide input during the development of the main study budget. Ensure all study-related information in VELOS is accurate and up-to-date to support timely payment processing by the Clinical Trials Finance Office (CT Finance). Respond to and assist CT Finance with sponsor inquiries related to invoicing, payment reconciliation, and financial reporting. Track participant stipends and maintain records of study-related procedures to support billing compliance. Represent the Pulmonary, Critical Care, and Sleep Medicine Research Division in cross-departmental working groups and special projects.