Clinical Research Coordinator II, Department of Urology

Research Project and Regulatory Management: Assist Principal Investigator(s) with implementation and coordination of clinical, translational, and health services research projects within the Department of Urology. Prepare, submit, and maintain regulatory documentation including IRB applications, protocol amendments, continuing reviews, informed consent documents, and sponsor-required submissions. Coordinate study start-up, activation, monitoring, and close-out activities while ensuring compliance with institutional, federal, and sponsor regulations. Coordinate project timelines, study documentation, investigator communications, and research team meetings across multiple concurrent studies. Assist with budget development, grant administration, and project tracking to ensure compliance with study and funding requirements. Clinical Research Data Collection and Database Management: Perform data abstraction and collection from electronic health records, institutional databases, registries, pathology reports, imaging systems, and study-specific data collection forms. Build, maintain, and administer REDCap databases and other research data management systems to study specifications. Conduct data quality assurance, validation, auditing, and reconciliation activities to ensure data integrity and protocol compliance. Generate data reports and maintain study datasets for clinical trials, observational studies, biomarker investigations, and quality improvement initiatives. Assist investigators in developing data collection methodologies and data management plans. Manuscript Development, Scientific Writing, and Dissemination : Support preparation, writing, editing, and submission of scientific manuscripts for peer-reviewed journals. Perform literature reviews, systematic reviews, meta-analyses, and evidence synthesis projects. Prepare abstracts, posters, oral presentations, and scientific meeting materials for local, national, and international conferences. Generate tables, figures, supplementary materials, and statistical summaries for publication and presentation purposes. Assist faculty, fellows, residents, and students with scientific writing and publication-related activities. Grant Development and Research Funding Activities: Assist in identifying funding opportunities from federal agencies, foundations, professional societies, and industry sponsors. Draft and prepare grant applications, progress reports, supporting documentation, biosketches, budgets, and research narratives. Coordinate submission of grant proposals and ensure compliance with institutional and sponsor requirements. Assist investigators with development of research aims, study methodologies, timelines, and supporting preliminary data. Research Methodology, Statistical Analysis, and Program Development: Assist investigators in study design, protocol development, clinical trial implementation, and quality improvement initiatives. Participate in statistical analyses and interpretation of study findings using appropriate software and analytical methods. Support biomarker discovery and validation projects, including studies utilizing spatial transcriptomics and related technologies. Contribute to continuous improvement of research processes and recommend refinements to research workflows and tools. Collaborate with multidisciplinary investigators, research staff, and external collaborators to advance departmental research objectives. Knowledge, Skills Abilities: Knowledge of IRB processes, human subjects research regulations, and Good Clinical Practice (GCP). Ability to develop and manage research databases, including REDCap, and collect data from electronic health records and research datasets. Ability to analyze and interpret research data and prepare reports, tables, and summaries. Strong scientific writing skills with the ability to prepare manuscripts, abstracts, grants, and presentations. Knowledge of clinical research methods, clinical trial operations, and evidence synthesis methodologies. Excellent organizational, communication, interpersonal, and problem-solving skills. Strong attention to detail and ability to manage multiple projects and deadlines simultaneously.