Clinical Applications Specialist Columbus or Cleveland Medical OEM Auto

Clinical Applications Specialist

Ohio Remote

Job Details Description

Ideal candidates will be located in the Columbus or Cleveland, Ohio areas.

Essential Duties & Responsibilities:

Implementation & Validation

• Support customers through method verification and correlation studies (precision, accuracy, reportable range) per CLSI standards.
• Participate in site readiness assessments, installation coordination, validation planning, and customer implementation meetings.
• Perform lot conversions and reagent changeovers per contract commitments, both on-site and remote, leveraging middleware accreditation tools wherever possible.

Training & Change Enablement

• Deliver on-site, supplemental operator training for users at all competency levels (super users, bench techs, supervisors).
• Promote adoption of OEM ’s digital training tools to scale learning post-go-live.
• Deliver on-site or remote product trainings or learning opportunities such as Lunch & Learns independently or in collaboration with cross-functional teams to help customers understand testing best practices, guideline changes, patient care benefits of test expansion opportunities, product functionality, etc.

Clinical & Workflow Expertise

• Provide subject-matter expertise on hemostasis testing, including workflow design, reflex logic, QC approach, and best-practice utilization of OEM assays (PT/INR, aPTT, Anti-Xa, D-Dimer, fibrinogen, Lupus Anticoagulants, and other specialty assays).
• Support customers in understanding assay principles, performance characteristics, and practical interpretation considerations as an applications ? resource, not as a substitute for the medical judgment of the laboratory’s medical director or pathologist.
• Guide laboratories on aligning their workflows with industry standards and OEM best practices while respecting each institution’s established medical governance and clinical decision authority.
• Apply data-driven insights from reagent utilization, QC trends, and error codes to make suggestions for customers to improve their performance or workflow.

Troubleshooting

• Support & Troubleshooting:
  Provide on-site and remote application support for OEM systems, diagnosing and resolving issues efficiently to minimize downtime or testing disruptions.
• Timely Response & Resolution:
  Prioritize service requests, manage workload effectively, and ensure that customer concerns are addressed promptly and thoroughly.
• Continuous Follow-Through:
  Provide ongoing updates and consistent communication with customers and manager until full resolution of their issues, ensuring they feel supported throughout the process.
• Escalate all open or reoccurring issues in a timely manner for prompt resolution.

Regulatory & Quality Assurance

• Provide supportive guidance to customers on CAP/CLIA/IQCP documentation and compliance practices.
• Continuously monitor changes in industry guidelines (e.g., CAP checklist updates, CLIA revisions, CLSI guideline updates, ISTH guidelines) and proactively incorporate these into training, verification templates, and customer guidance in collaboration with the Training department and Scientific Affairs.
• Communicate relevant compliance updates to customers in a clear, actionable way to help them stay inspection-ready and aligned with best practices.
• Provide customers only the most current CLSI-based SOPs as developed by the organization.
• Follow all internal SOPs

Connectivity & Middleware Integration

• Partner with internal and customer stakeholders to implement LIS interfaces, flags, and auto-verification rules.
• Support rule performance and minimize TAT, reruns, and manual interventions.
• Actively use and promote OEM digital tools and middleware solutions for accreditation, automation, and data integrity.

Customer Success & Commercial Partnership

• Monitor reagent consumption, QC performance, maintenance patterns, and service interactions collaboratively with your Customer Care Team to proactively identify improvement opportunities and prevent issues before they escalate.
• Proactively visit customers to ensure they are operating in alignment with OEM best practices, following proper workflows, and using products according to OEM requirements. Provide supportive…