David Morris
- Role
- Clinical Site Monitoring Manager Sr Cra (Study Startup) at Fractyl Health
- Location
- Washington, NJ, US
- LinkedIn followers
- 500 followers
About David Morris
I am very determined, self-motivated, and a go-getter. Having a can-do attitude, life is…
Experience
Clinical Site Monitoring Manager Sr Cra (Study Startup)
Jan 2023 — Present · Lexington, MA, US
The Revita T2Di Pivotal Study (REVITALIZE 1): “A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Subjects with Type 2 Diabetes on Insulin Therapy”, Pivotal Study to support PMA submission.\\\\n Conduct the project according to the monitoring plan: Site Evaluation Visit (SEV) Remote and Onsite, Site Initiation Visit (SIV) Remote and Onsite, CTMS.\\\\n SEV Presentation-PP:(Study Design, Study Objectives, Study Endpoints, Investigational Product – The RevitaTM System, Patient Population, Inclusion/Exclusion Criteria, Study Assessments, Subject Randomization, Study Blinding, Diabetes Care, Study Status, Expected Vendors. Site IMVs, EDC queries, EMR Search Criteria, etc.\\\\n SEV Presentation: Revita® DMR Procedure Animation: SIV Presentation-PP/PDF:(DMR/Sham Procedure, Study Overview, Study Design, Study Stages, Schedule of Visits & Assessments, Glycemia Management, Randomization & Blinding, Subject Compliance/Covid-19, Mitigation Strategies, Subject Recruitment Strategy, Safety Reporting & Committees, Monitoring, ICH-GCP & GCD, Vendors, etc.).\\\\n Re-engaging with Active Sites:(Notify sites of FDA-approved changes, Utilize the site dedicated teams channels, Utilize MSLs and CSs in presentations, Communicate openly about obstacles/ red flags, Assist with addressing questions and site barriers, COLLABORATE!).\\\\n Performed Study Assessments: Schedule of Activities Pivotal \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
Education
New Jersey Institute of Technology
Bachelor of Science (B.S.), B.S. Industrial Engineering
New Jersey Institute of Technology
Master's of Science, Pharmaceutical Systems Management
Rutgers, College of Nursing
Professional Certification, Clinical Research Training & CRC (Barnett International Inc.)
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