Yale School of MedicineClinical Data Coordinator 2
May. 2024New Haven, Connecticut, United StatesAs the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols, I manage and evaluate all aspects of clinical trial conduct, including study initiation, execution, maintenance, completion, and administration. I contribute to study feasibility reviews, ensuring adherence to protocols, and oversee accurate documentation, participant recruitment, and compliance with ICH/GCP, federal regulations, and institutional guidelines. I identify and report instances of noncompliance, advise Principal Investigators on protocol issues, and analyze and convey study data. Additionally, I oversee adverse event tracking, assess trial execution, and provide recommendations for improvement. I collaborate with Investigators and Research Managers on corrective action plans, contribute to CRC training design, participate in audits, and monitor regulatory updates.