Clinical Research Specialist, Senior (Spanish Bilingual) - School of Nursing

About the role

The Duke University School of Nursing Clinical Research Unit is seeking a Clinical Research Specialist, Sr. to support SER Familia, an NIH-funded, community-engaged research trial evaluating a community health worker intervention for Latino immigrant families.

Responsibilities

• Coordinate study operations and day-to-day research activities for SER Familia, ensuring adherence to NIH requirements, IRB approvals, institutional policies, study protocols, and Standard Operating Procedures (SOPs)
• Lead participant-facing activities, including bilingual recruitment, screening (in person and by phone), scheduling, informed consent, data collection, and follow-up for minimal risk clinical research studies
• Develop and implement culturally responsive recruitment and retention strategies in partnership with El Centro Hispano and other community stakeholders to support enrollment goals and participant engagement
• Serve as a study ambassador in academic, clinical, and community settings, representing SER Familia at meetings, events, committees, workgroups, and educational forums to support outreach and dissemination
• Maintain comprehensive study documentation, including participant-level records, consent documentation in the electronic medical record, adverse event information, regulatory files, and secure project folders
• Apply regulatory and institutional knowledge to assist with protocol submissions, amendments, SOP development, and recognition of required agreements (e.g., MTAs, CDAs, DUAs, DTAs), escalating to appropriate stakeholders when needed
• Conduct and document protocol-specific visits, interviews, and assessments independently, following approved protocols, departmental workflows, and SOPs
• Monitor recruitment, retention, and data quality, employing proactive strategies to support participant needs, minimize missing data, and resolve discrepancies in accordance with quality assurance standards
• Enter, verify, correct, and manage study data, run routine reports and summaries, and follow required processes to ensure data integrity, security, and provenance
• Support adverse event identification and documentation under supervision, ensuring accurate and timely reporting per protocol and IRB guidelines
• Assist with preparation of study materials and outputs, including recruitment reports, study progress reports, tables, data visualizations, and lay summaries for participants and collaborators
• Manage study logistics, including preparation of research visit materials, tracking supplies and equipment for minimal risk studies, coordinating participant payments, and supporting study closeout activities

Requirements

• Associate degree
• Minimum of one year of relevant clinical research or related experience (completion of the DOCR NC state-approved Clinical Research Pre-Apprenticeship may substitute for one year of experience)
• Requires fluency in Spanish and English (speaking, reading, writing, and comprehension)
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint

Preferred Qualifications

• Experience working with Latino, immigrant, or culturally diverse populations
• Prior experience supporting NIH-funded, investigator-initiated, or community-based research studies
• Experience with participant recruitment, screening, scheduling, consent, and retention activities
• Familiarity with IRB-regulated research environments, study documentation, and clinical research management systems

Other Requirements

• Evening and/or weekend work may be required on a rotating basis to support participant availability and community events
• Ability to travel locally to community sites, recruitment events, and participant visits (reliable transportation required)