Clinical Training & Implementation Specialist
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Job Location:
Manchester, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
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:
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 DEKAs 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.
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
- 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
- Required travel requirements: 50-75% travel. Local (Office) and Clinical site requirements.
- Phase 1: Manchester NH
- Phase 2: Cleveland OH
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 DEKAs 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.
Required Experience:
Senior IC
Key Skills
- Employee Orientation
- Dayforce
- Human Capital Management
- Visio
- Business Process Modeling
- Process Mapping
- Ceridian
- Smartsheet
- Salesforce
- Peoplesoft
- Project Management
- Microsoft Project
About Company
DEKA Research and Development is perhaps best known for its founder and president Dean Kamen -- and for the Segway Personal Transporter he invented. DEKA is a design and engineering firm that develops innovative technologies, many of them in the field of medical devices. The Segway it ... View more
