Kunj Patel

WORK HISTORY

EDUCATION

ABOUT KUNJ PATEL

I’m a certified Clinical Research Coordinator (ACRP-CCRC) with over 5 years of experience supporting FDA-regulated clinical trials across a wide range of therapeutic areas—Oncology, Cardiology, Neurology, Diabetes, Obesity, and Pediatrics etc.I’ve worked on Phase II to IV studies, ensuring every protocol is followed with precision, care, and ethical responsibility.With a Master’s degree in Pharmacology and certifications in ICH-GCP and TCPS-CORE, I bring both scientific knowledge and practical expertise to the table. I’ve managed everything from patient recruitment and informed consent to SAE/AE reporting, EDC data entry (REDCap, iMedidata, Clinphone many more), and site monitoring support with LEAN/ SIX SIGMA approach for clinical operations with extensive project management experience. Communication with IEC.I have experience as negotiator and handling budget preparation which makes me stronger in clinical finance management.Data management experience with PHIPA and confidentiality maintenance throughout clinical trial. Experience of biological samples processing, storage and shipping under IATA regulations.Expertise in dealing with vendors sponsors/CROs/SMOs/Local labs/Central labs etc. Experience of conducting multiple SQV/SIV/SMV/SCV and archival of clinical research documents according to regulatory guidelines.I’m passionate about contributing to research that truly makes a difference in people’s lives. Whether it’s working closely with investigators, sponsors, or study participants, I believe in the power of collaboration, accuracy, and heart in clinical research.let’s connect!