Research Nurse Specialist
Current• Assist in the development and implementation of phase I and phase II clinical research protocols to ensure compliance with regulatory requirements.• Evaluate clinical study subjects to confirm protocol eligibility, educate on participation and obtain informed consent for clinical trials. • Communicate with study subjects and their families about protocol scheduling and requirements.• Assess and grade patient adverse events as per protocol and CTCAE guidance.• Assist with and ensure research samples are collected, stored, and shipped as per protocol. • Prepare IRB documentation, including initial submissions, amendments, protocol violations, continuing review, and informed consent documents.• Coordinate sponsor site visits for safety and routine monitoring. • Actively participate in data quality assurance and improvement through review of database submissions.
