Clinical Research Coordinator II

Clinical Research Coordinator II role overseeing clinical site activities and ensuring regulatory compliance, patient safety, and data integrity. Responsible for conducting studies per FDA/GCP guidelines, managing patient interactions, and maintaining accurate study documentation in a clinical environment.

Responsibilities Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines Schedule subject visits, perform screening and protocol procedures including vital signs and ECGs Record patient information and test results on required forms and sponsor systems accurately Ensure IRB approval and compliance throughout study duration Maintain source documents, update patient files, and manage case report forms and EDC data Requirements Bachelor's degree or equivalent formal academic/vocational qualification BLS certificate required 2+ years of relevant clinical research experience or equivalent combination of education and training Solid understanding of GCP, SOPs, informed consent, and safety monitoring Proficiency in basic computer applications and clinical research systems Strong attention to detail, organizational skills, and ability to work independently Good communication skills, interpersonal abilities, and English fluency