Clinical Training

5 hours ago

Manchester, New Hampshire, United States DEKA Research & Development Full time

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

Skills you will need to make an impact:

  • 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

Travel:

  • Required travel requirements: 50-75% travel. Local (Office) and Clinical site requirements.

  • Phase 1: Manchester, NH

  • Phase 2: Cleveland, OH

About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.

Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.

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