Clinical Training & Implementation Specialist

DEKA Research & Development•Manchester, NH

About The Position

The Clinical Training & Implementation Specialist [CTIS] shall work with the Clinical Lead and extended team to develop comprehensive, multi-modal training plan and assets to be used to provide training and demos to RWE clinical teams. How you will make an impact: Lead end-to-end clinical strategy (training, implementation/operations, and qualitative assessment of observed execution) for appropriate clinical trials across DEKA-designated disease/therapeutic areas. Oversee protocol implementation, including the development of operational workflows, staff training, and performance monitoring. Coordinate all aspects of patient engagement, including recruitment, informed consent, pre-screening, medical evaluations, and follow-up visits in both inpatient and outpatient settings, ensuring an excellent patient experience and high retention rates. Prepare, review, and submit regulatory documentation to IRBs, FDA, and sponsors, maintaining strict adherence to GCP and institutional guidelines. Mentor and train new staff on study procedures, protocol adherence, safety standards, and data collection. Work with RWE local stakeholders as well as members of the RWE Steering Committee to ensure the clinical elements of the RWE Plan is in alignment with objectives for both parties, and executed as outlined. Work with the internal and external Team(s) to identify, define, and implement metrics to be monitored during the RWE. Provide observational support during onboarding and initial use. Follow SOP related to Tech/Clinical Support Monitoring, Reporting and Follow up. Remediate as needed. Ensure tracking to RWE milestones. Consult with other DEKA projects where clinical trial or clinical evaluations are contemplated

Requirements

RN, preferred. Will consider others with Medical Device Training experience in-hospital or infusion center
Degree Requirements: BSN (or MSN) preferred, but will evaluate individually.
Clinical Systems & Platform / EMR/EHR Experience including Epic, Cerner, Meditech, Allscripts
Training Content creation and delivery
Understand of Clinical Best Practice and Quality/Performance Metrics
Extensive previous experience with at least two (2) IV pumps
Experience leading end-to-end clinical strategy
Familiar with methods to coordinate all aspects of patient engagement, including recruitment, informed consent, pre-screening, medical evaluations, and follow-up visits in both inpatient and outpatient settings
Able to prepare, review, and submit regulatory documentation to IRBs, FDA, and sponsors, maintaining strict adherence to GCP and institutional guidelines.
Able to mentor and train new staff on study procedures, protocol adherence, safety standards, and data collection.
Proficient with Microsoft Office Suite
Motivated, energetic and a self-starter

Responsibilities

Lead end-to-end clinical strategy (training, implementation/operations, and qualitative assessment of observed execution) for appropriate clinical trials across DEKA-designated disease/therapeutic areas.
Oversee protocol implementation, including the development of operational workflows, staff training, and performance monitoring.
Coordinate all aspects of patient engagement, including recruitment, informed consent, pre-screening, medical evaluations, and follow-up visits in both inpatient and outpatient settings, ensuring an excellent patient experience and high retention rates.
Prepare, review, and submit regulatory documentation to IRBs, FDA, and sponsors, maintaining strict adherence to GCP and institutional guidelines.
Mentor and train new staff on study procedures, protocol adherence, safety standards, and data collection.
Work with RWE local stakeholders as well as members of the RWE Steering Committee to ensure the clinical elements of the RWE Plan is in alignment with objectives for both parties, and executed as outlined.
Work with the internal and external Team(s) to identify, define, and implement metrics to be monitored during the RWE.
Provide observational support during onboarding and initial use.
Follow SOP related to Tech/Clinical Support Monitoring, Reporting and Follow up. Remediate as needed. Ensure tracking to RWE milestones.
Consult with other DEKA projects where clinical trial or clinical evaluations are contemplated