Clinical Research Nurse D

Job Description Summary

Provides leadership in the coordination of clinical trials and unit-related projects. Oversees study approvals, participant enrollment and consent, visit scheduling, medication administration, data collection, and regulatory documentation to ensure compliance with institutional and sponsor requirements. Serves in a lead capacity by guiding research coordinators and assistants, supporting project timelines, and preparing for monitoring visits and audits.

Job Responsibilities

• Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation
• Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel according to applicable regulations and policies
• Coordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as applicable), monitoring subjects for post-administration adverse events or reactions
• Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures. Ensure preparation of all required study related documents for submission to all applicable institutional committees for review and approval to start trial.
• Ensure preparation of study related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start up
• Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures. Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events
• Assist with protocol development to ensure logistical feasibility of all study related procedures and study work-flow
• Orient and mentor new unit staff and function as resource for current staff
• Other duties and responsibilities as assigned