Full-Time

Senior Clinical Research Specialist

Spanish Bilingual, School of Nursing

Duke University

Duke University

No salary listed

Durham, NC, USA

In Person

Evening/weekend work may be required; local travel to community sites.

Associate's

Category
Biology & Biotech (1)
Required Skills
Ruby
Word/Pages/Docs
Excel/Numbers/Sheets
PowerPoint/Keynote/Slides
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
  • 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)
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, 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

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