Registered Nurse for Clinical Trials

Benefits

Qualifications

• •Proven supervising experience in a clinical or research setting with strong leadership capabilities
• •Extensive knowledge of clinical trials management, including regulatory compliance and documentation review processes
• •Proficiency in medical terminology, blood sampling techniques such as phlebotomy, and vital signs measurement
• •Familiarity with EMR systems, data management tools, statistical software, and CDISC standards for clinical research data
• •In-depth understanding of FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and clinical development processes
• •Clinical laboratory experience combined with analysis skills for interpreting laboratory results within trial protocols
• •Certification in Good Clinical Practice (GCP) from a recognized issuer for CA or equivalent certification such as ICH GCP certificate
• •Strong communication skills to facilitate clear documentation review, patient interactions, and team collaboration
• •5 more items(s)

Responsibilities

• •In this vital role, you will be at the forefront of advancing medical knowledge by managing and monitoring clinical trial participants, ensuring strict adherence to regulatory standards, and maintaining impeccable documentation
• •Your expertise will help shape innovative therapies and improve patient outcomes worldwide
• •Conduct thorough patient assessments, including vital signs, blood sampling, and monitoring of clinical laboratory results to ensure participant safety and data accuracy
• •Manage and oversee all aspects of clinical trial procedures, ensuring compliance with FDA regulations, ICH GCP guidelines, and CDISC standards for data collection and management
• •Supervise and coordinate the work of junior staff or research assistants involved in clinical trials management and data collection activities
• •Review and verify clinical documentation, including consent forms, case report forms, and EMR (Electronic Medical Records) systems to maintain high-quality records
• •Monitor patient progress throughout the trial duration, promptly identifying adverse events or protocol deviations for immediate action
• •Ensure strict adherence to HIPAA regulations and other privacy standards to protect participant confidentiality at all times
• •Collaborate with multidisciplinary teams including physicians, laboratory personnel, and statisticians using statistical software for data analysis and reporting
• •6 more items(s)