Clinical Research Coordinator II, Department of Urology

Duties & Responsibilities

• Research Project and Regulatory Management
• Prepare, submit, and maintain regulatory documentation including IRB applications, protocol amendments, continuing reviews, informed consent documents, and sponsor-required submissions.
• Career Highlights
• 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.
• Aid in 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.
• Aid 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.
• Aid faculty, fellows, residents, and students with scientific writing and publication-related activities.

Grant Development And Research Funding Activities

• Aid 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.
• Career Highlights
• Coordinate submission of grant proposals and ensure compliance with institutional and sponsor requirements.
• Aid 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.