Implementation Specialist (crc/cra/monitor)

New Castle, DE, US, United States

Job Description

Join Our Team as an Implementation Specialist at IgniteData!



IgniteData is transforming clinical trials through intelligent automation, enabling real-time, secure transfer of clinical data between healthcare providers and life science companies. As an Implementation Specialist, you will leverage your hands-on site experience (CRC/CRA/Monitor) to help research centers adopt Archer, our regulatory-grade EHR-to-EDC automation platform. By eliminating manual data entry and streamlining data workflows, you'll play a key role in improving the daily working experience of site staff, reducing administrative burden, enhancing data quality, and ultimately increasing job satisfaction for clinical research professionals.


What

You'll

Do




Serve as a subject-matter expert on clinical research workflows for partner sites adopting Archer (EHR-to-EDC automation). Partner with research coordinators, investigators, data managers, and IT teams at hospitals and cancer centers to map current workflows and design efficient, compliant data flows. Support end-to-end deployment of Archer at research sites, including requirements gathering, configuration, testing, and go-live activities. Participate in and lead user acceptance testing (UAT) for new studies and site implementations, validating EHR-to-EDC mappings and troubleshooting data issues. Review data flows between EHR and EDC to ensure completeness, accuracy, and alignment with study protocols and data standards. Provide training, coaching, and day-to-day support to site staff using Archer, helping them transition away from manual data transcription. Monitor product performance and site feedback, flagging recurring issues or enhancement opportunities to Product, Engineering, and Customer Success. Contribute to SOPs, work instructions, and documentation to ensure workflows remain inspection-ready and aligned with ICH-GCP and regulatory expectations. Support internal and external stakeholders (sponsors, CROs, sites) with clear updates on implementation progress, timelines, and risks.

What

You'll

Bring




3+ years of hands-on experience as a Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), or Clinical Research Monitor in a Clinical research site, sponsor, CRO, or academic research setting. Strong understanding of clinical trial operations, including source documentation, informed consent, AE/SAE reporting, protocol deviations, and data query management. Direct experience working with EHR systems (e.g., Epic, Cerner, Meditech) and EDC platforms (e.g., Medidata Rave, Oracle, REDCap or similar). Solid familiarity with ICH-GCP guidelines and relevant regulatory frameworks (e.g., FDA, EMA) plus patient privacy regulations (e.g., HIPAA, GDPR). Comfort engaging with clinicians, coordinators, and sponsor partners, with the ability to translate operational needs into clear requirements. A process-minded, detail-oriented approach with a bias toward structured documentation, consistency, and continuous improvement. Strong communication skills: concise writing, clear meeting facilitation, and executive-ready updates when needed. Comfort working in a dynamic, high-growth, technology-driven environment with evolving processes and priorities.

Nice to Have




Experience with eSource, EHR-to-EDC, or other clinical data interoperability technologies. Background in oncology or other complex, data-heavy therapeutic areas. Familiarity with data standards (e.g., CDISC, SDTM), HL7/FHIR, or clinical data mapping concepts. Prior experience in a healthtech, SaaS, or startup environment. * Comfort interpreting operational metrics and using dashboards or spreadsheets to track site performance and adoption.

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Job Detail

  • Job Id
    JD6464563
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    USD
  • Employment Status
    Permanent
  • Job Location
    New Castle, DE, US, United States
  • Education
    Not mentioned