Job Information
UNIVERSITY OF TEXAS AT AUSTIN RN Clinical Research Coordinator or Senior RN Clinical Research Coordinator in Austin, Texas
RN Clinical Research Coordinator:Study coordination and implementationProtocol Management: Understand, implement, and ensure adherence to clinical research protocols.Study Setup: assist in the initiation of studies, including feasibility assessments and coordination with sponsors.Participant Recruitment: Screen and enroll participants, ensuring they meet inclusion/exclusion criteria.Informed Consent: Educate participants about the study, obtaining and documenting informed consent.Study Visits: Conduct and coordinate patient visits, assessments, and data collection per protocol requirements.Medical Procedures: Perform clinical procedures (e.g., blood draws, vital signs, and medication administration) as required by the study.Data Accuracy: Collect, document, and manage study data in accordance with regulatory and institutional requirements.Regulatory activitiesAssist PI with regulatory activitiesIRB Submissions: help prepare and submit required documents to Institutional Review Boards (IRBs).Protocol Amendments: assist with modifications to protocols and other study-related documents.Regulatory Compliance: ensure all study documentation is accurate, complete, and compliant with GCP (Good Clinical Practice) and other regulations.Audits: Maintain accurate and complete records for audits, participate in internal and external audits to ensure compliance.Study monitoring visits: participate in sponsor-led study monitoring visits.Administrative responsibilitiesBudget Management: assist PI with budget preparation and financial accountabilityResource Allocation: assist PI with management of study supplies and resources.Sponsor Liaison: assist in communications with study sponsors and Contract Research Organizations (CROs) regarding study progress and updates.Assist in communications with office of sponsored projects, finance department or other internal offices involved in the conduction of clinical research.Other related duties as assigned. Senior RN Clinical Research Coordinator:Study coordination and implementationProtocol Management: Understand, implement, and ensure adherence to clinical research protocols.Study Setup: lead the initiation of studies, including feasibility assessments and coordination with sponsors.Participant Recruitment: Screen and enroll participants, ensuring they meet inclusion/exclusion criteria.Informed Consent: Educate participants about the study, obtaining and documenting informed consent.Study Visits: Conduct and coordinate patient visits, assessments, and data collection per protocol requirements.Medical Procedures: Perform clinical procedures (e.g., blood draws, vital signs, and medication administration) as required by the study.Data Accuracy: Collect, document, and manage study data in accordance with regulatory and institutional requirements.Troubleshoot and address critical issues in patient safety and study execution.Regulatory oversightLead and oversee regulatory activitiesIRB Submissions: Prepare and submit required documents to Institutional Review Boards (IRBs).Protocol Amendments: Assist with modifications to protocols and other study-related documents.Regulatory Compliance: Ensure all study documentation is accurate, complete, and compliant with GCP (Good Clinical Practice) and other regulations.Audits: Participate in internal and external audits to ensure compliance.Study monitoring visits: prepare and participate in sponsor-led study monitoring visits.Training and Supervision:Supervision: supervise, train, and mentor junior staff or other members of the research team; assist in staff project allocationEducation: Stay updated on clinical research developments and share knowledge with the team.Administrative responsibilities:Budget Management: oversee budget and financial accountabilityResource Allocation: Oversee and manage study supplies and resources.Communicates with Office of Sponsored Projects, Finance department or other internal office involved in clinical researchSponsor Liaison: C mmunicate with study sponsors and Contract Research Organizations (CROs) regarding study progress and updates.Other related duties as assigned.