Clinical Research Nurse

Overview

• Serve as a Clinical Research Nurse supporting clinical trials and studies in compliance with regulatory standards and protocols.
• Perform clinical procedures such as venipunctures, injections, and infusions under study protocols and guidelines.
• Collaborate with site managers and investigators to ensure successful execution of assigned studies.
• Maintain patient confidentiality and adhere to HIPAA guidelines during all study-related activities.
• Document and report adverse events, deviations, and non-compliance promptly and accurately.
• Engage in study start-up activities, including training and preparation for site initiation visits.
• Ensure proper handling and accountability of lab specimens and investigational products.
• Support recruitment and enrollment efforts for study participants as needed.

Key Responsibilities & Duties

• Screen patients for study eligibility and obtain informed consent for participation.
• Perform vital signs, ECGs/EKGs, venipunctures, and administer investigational products.
• Document patient visits and study data in electronic data capture systems.
• Coordinate study visits and manage appointment reminders for participants.
• Maintain study-specific supplies and ensure proper inventory management.
• Prepare for and attend investigator meetings and site initiation visits.
• Report serious adverse events and deviations to sponsors and IRBs as required.
• Ensure compliance with FDA, GCP, ICH regulations, and company SOPs.

Job Requirements

• Bachelor of Science in Nursing (BSN) and active RN license in the state of work.
• Minimum of 1 year clinical experience; 2 years preferred.
• Proficiency in clinical procedures such as injections, vitals, EKGs, and phlebotomy.
• Strong organizational skills and attention to detail in documentation and reporting.
• Effective communication skills for collaboration with team members and study participants.
• Ability to handle sensitive information confidentially and professionally.
• Proficiency in Microsoft Office applications and electronic health records.
• BLS certification required; bilingual proficiency in English/Spanish is a plus.