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