Alec Spinelli MBA's Linkedin Analytics

I didn’t plan to become an author and clinical research expert. I planned to build clinical trials that work. My journey started at the site level and took me from CRA to CTM to Project Manager, across cardiology, oncology, neurology, dermatology, and ophthalmology studies. Along the way, I’ve led high-performing Clinical Operations, Start-up, and Project Management teams, navigated FDA-regulated IND and IDE trials, developed SOPs, and built protocols from scratch. I’ve worked across Phases I–IV, mentored dozens of CRAs, and managed site start-up and cross-functional teams of 20+. But something was missing. A clear guide for those trying to break into (or move up in) clinical research. So, I wrote the “How to Snag That First” book series because the industry needs more clarity and guidance. I wrote ICH-GCP E6(R3) – The Quick Resource Guide for Clinical Research Professionals to help others understand the real-world application of GCP principles, not just memorize them. Mastering Clinical Trials was created to give research professionals a single, comprehensive reference for every stage of a trial. And Clinical Research: The Best Career You Never Heard Of was born out of my passion for showing others the incredible opportunities in this field; especially those who never knew this path existed. My mission is to help you land that first CRA, Sr. CRA, or CTM job and then learn, grow, and thrive once you're there. If you're passionate about clinical research, ready to level up, or just looking for someone who's been there, let’s connect. 📚 Author | 🎤 Speaker | 💼 Clinical Research SME ICH GCP E6(R3) | Study Start-Up | Project Leadership