Clinical Research Coordinator II

Clinical Research Coordinator II

The primary responsibility of the Clinical Research Coordinator II is to manage all aspects of conducting clinical trials. This includes screening, enrolling, and closely monitoring study patients while ensuring protocol compliance. The Coordinator acts as a liaison between patients, investigators, the Institutional Review Board (IRB), and sponsors. Additionally, the role is responsible for data and source documentation, adverse event reporting, and the maintenance of complete regulatory files under direct supervision.

• Screening and enrollment of study participants.
• Maintaining accurate study documentation and regulatory files.
• Reporting adverse events per protocol and regulatory requirements.
• Coordinating communication among patients, investigators, IRB, and sponsor.
• Ensuring compliance with federal regulations and Good Clinical Practice guidelines.
• Supporting protocol development and submission through IRB processes.

• In-depth knowledge of Good Clinical Practice (GCP) and protocol requirements.
• Excellent interpersonal skills to interact with patients and the general public.
• Ability to obtain and maintain all required CITI training certificates.
• Ability to acquire and maintain credentialing at required institutions (e.g., Tulane Medical Center, Veterans Administration Hospital/New Orleans, Louisiana, and University Medical Center).

• Bachelor's degree or RN with current Louisiana state licensure plus one (1) year of related work experience.
• OR LPN with current Louisiana state licensure plus four (4) years of related work experience.

• Knowledge of IRB submission processes and requirements.
• Familiarity with Good Clinical Practices as set forth by federal regulations.