Divyesh Kukadiya

About Divyesh Kukadiya

I am a seasoned clinical research professional with a strong focus on clinical trial monitoring and clinical trial management. My expertise spans Study Start-Up, Site Initiation Visits (SIVs), Routine Monitoring, Source Data Verification (SDV), and Close-Out Visits, ensuring trials meet the highest standards of quality and regulatory compliance.I have experience conducting onsite and remote monitoring visits across diverse sites and have successfully managed clinical trials, including industry-sponsored, consortium-based, and investigator-initiated studies.I am skilled in site management, Trial Master File (TMF) oversight, and ensuring inspection readiness. I am passionate about advancing clinical research to bring innovative treatments to patients and improve outcomes through efficient, compliant, and high-quality trial execution.

Experience

1. Senior Clinical Research Associate Local Study Manager

   Children\'s National Hospital

   Jul 2017 — Present · Washington, DC, US

   Serve as Senior CRA and Study Lead for early-phase investigator-initiated IND studies, combining traditional monitoring duties with operational coordination responsibilities.• Support oversight of clinical study coordinators, ensuring protocol adherence, timely documentation, safety reporting, and high-quality data collection.• Work cross-functionally with internal teams including data management, regulatory affairs, clinical supplies, and GMP, Pharmacy to ensure timely trial execution and alignment with ICH-GCP.• Interface with EDC developers to review, revise, and test CRFs aligned with visit schedules and protocol endpoints.• Coordinate procurement of study supplies (e.g, research tubes, kits), working with internal stakeholders and vendors to ensure study readiness.• Facilitated the implementation of DocuSign workflows for regulatory and site documentation processes, streamlining study documentation handling.• Prepare and review ICFs, IRB submissions, protocol amendments, and FDA forms, supporting regulatory readiness and compliance.• Conduct pre-study, initiation, monitoring, and close-out visits with source data verification (SDV), ICF review, AE/SAE documentation review, and investigational product (IP) accountability.• Perform quality control (QC) reviews of IND submissions, and actively contribute to inspection readiness and internal audit preparation.• Assist in developing local trial-specific procedures, and study-specific tools to enhance operational efficiency.• Participate in continuous process improvement, including SOP development and inspection-readiness planning.

Education

• Long Island University

  M.S., Pharmacology & Toxicology

  2006 — 2008