Description

Conversation with Clinical Development Veteran Marshall Cool "There are a lot of things we can do, but we want to make sure we're doing what we want to do" - Marshall Cool In this interview, I talk to one of my dear friends Marshall Cool, who also turns out to be a clinical research veteran. Marshall brings to us his over two decades of clinical development experience, including his time at Abbott Vascular, leading one of the most exciting post-approval medical device studies, XIENCE V USA. Marshall also has significant experience managing Investigator Sponsored Studies (ISS) and clinical research organizations, details of which he shares with us during this interview. In addition, Marshall is an avid reader and loves books. Please enjoy my conversation with Marshall Cool. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing "save as."

Selected Links from the Episode:

• Connect with Marshall Cool

LinkedIn

• CSU Annual Biotechnology Symposium
• Bristol-Myers Squibb
• Abbott
• Seth Godin Blog
• Center for Disease Control
• National Institute of Health
• Office of Inspector General
• Medical Affairs Strategic Summit (West)
• Medical Affairs Strategic Summit (East)
• ACRP Investigator Initiated and Sponsored Research Interest Group

Books Mentioned:

• The Road to Character by David Brooks
• Chronicles of Narnia by C.S. Lewis and Pauline Baynes
• Linchpin: Are You Indispensable by Seth Godin
• The Checklist Manifesto: How to Get Things Right by Atul Gawande

Show Notes:

• Description of what a clinical researcher does [02:10]
• Early days in clinical research [04:23]
• Roles and responsibilities of a clinical research associate (CRA) [08:55]
• You don't need an M.D. or Ph.D. to be in clinical research [10:55]
• Relocating for jobs [13:20]
• Transition from pharma to medical device clinical trials [15:55]
• What to do when you lose your job [19:46]
• Getting into the habit of reading and how it can help your clinical research job [26:31]
• Getting to First Patient In (FPI) for a post-approval medical device study [31:50]
• Onboarding a clinical research organization (CRO) [39:15]
• Investigator sponsored studies (non-company sponsored research) [41:30]
• Starting your career in Phase I-III research [45:45]
• Marshall's #1 advice to listeners [56:30]
• My motivations for starting the Clinical Trial Podcast [1:01:33]

QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.