About The Position

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. In this role, the specialist will be a key operational and community-facing member of the study team, responsible for translating complex research protocols into participant-centered, culturally responsive research activities. The position involves close collaboration with the Principal Investigator, Research Practice Manager, study staff, and community partners to ensure successful protocol implementation across all study phases. This role is suited for a detail-oriented research professional who thrives in field work, values relationship-based recruitment, and is dedicated to advancing health equity through bilingual clinical research.

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)
  • Fluency in Spanish and English (speaking, reading, writing, and comprehension)
  • Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint

Nice To Haves

  • 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

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

Benefits

  • Comprehensive and competitive medical and dental care programs
  • Generous retirement benefits
  • Wide array of family-friendly and cultural programs

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Education Level

Associate degree

Number of Employees

101-250 employees

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