Clinical Research Coordinator (Spanish Bilingual) - School of Nursing
Duke University · Durham, NC · 1 mo ago
Analyst$60k/yrFull-time
About the role
Duke University School of Nursing is seeking a Clinical Research Coordinator (Spanish-speaking) to join our research team focused on improving outcomes for English- and Spanish-speaking patients with traumatic brain injury (TBI) and their family caregivers as they transition home from acute hospital care.
Responsibilities
- Conduct participant screening and recruitment
- Perform daily screening of electronic medical records to identify eligible patients with TBI
- Recruit and enroll participants, including English- and Spanish-speaking individuals
- Implement strategies to maintain recruitment and retention rates; identify and escalate challenges
- Lead study visits and data collection activities
- Conduct longitudinal study visits and individual interviews in English and Spanish
- Obtain and document informed consent for simple to complex studies, including those requiring Maestro Care orders
- Plan and execute complex study visits; support and train other staff as needed
- Manage study operations and regulatory compliance
- Maintain participant- and study-level documentation, including complex interventional protocols
- Prepare for audits and monitoring visits; address findings and ensure compliance
- Develop and maintain SOPs, protocol documentation, and regulatory submissions
- Communicate with IRB and support development of consent documents and regulatory materials
- Recognize when agreements (MTAs, CDAs, DUAs, DTAs) are required and coordinate accordingly
- Collect, enter, and validate study data; ensure accuracy and completeness
- Develop and implement data collection tools, SOPs, and quality assurance processes
- Map data flow across systems (EHR, EDCs, mobile platforms)
- Ensure data security, integrity, and compliance with institutional policies
- Conduct qualitative analyses using tools such as NVivo or Atlas.ti
- Support quantitative analysis using statistical software (SAS, R, SPSS) under supervision
- Prepare tables, visualizations, reports, and participant-facing summaries
- Support study and site management
- Track participant accrual and consent documentation in clinical research management systems (e.g., OnCore)
- Manage study activities, including visit scheduling and protocol tracking
- Adequate supplies and proper functioning of study equipment
- Prepare studies for closeout and long-term document storage
- Ensure ethical conduct of research
- Identify and report adverse events (AEs) and collaborate with PI on evaluation and reporting
- Ensure ethical standards are met in all participant interactions and study procedures
- Contribute to scientific and scholarly activities
- Conduct literature reviews and synthesize findings
- Contribute to manuscripts, presentations, and posters
- Serve as a co-author on publications and presentations
- Choose Duke
- Engage in ongoing training and professional development opportunities
- Apply clinical research expertise to solve problems and improve processes
- Lead or facilitate interdisciplinary team meetings
- Communicate effectively across teams to achieve study objectives
Requirements
- Minimum Requirements: Associate’s degree plus a minimum of two years of relevant experience (e.g., research, clinical interaction, study population engagement, or program coordination) OR Bachelor’s degree.
- Preferred Qualifications: Experience working on randomized controlled trials, experience in clinical research or healthcare-related environments, experience working with patient populations, particularly those with complex medical conditions.
- Skills: Ability to support both qualitative and quantitative data collection and analysis, proficiency in Microsoft Office and web-based applications, experience with REDCap, Qualtrics, and NVivo (preferred), ability to use statistical tools such as SAS, R, or SPSS (under supervision).
Qualifications
- Fluency in Spanish and English (speaking, reading, writing, and comprehension)
- Other Requirements: Forward- and back-translation of study materials between English and Spanish, flexibility to work evenings and weekends as needed, knowledge of regulatory and institutional research policies and procedures