Job Title: Clinical Research Nurse

Job Description

The Clinical Research Coordinator II RN (CRC-II RN) plays a pivotal role in the research institute, operating under limited supervision to plan, coordinate, evaluate, and perform nursing care for participants, while collecting data for assigned research projects. This role adheres to study-specific protocol guidelines and communicates effectively with Principal Investigators, Sub-Investigators, Clinical Research Leads, and research support staff. The CRC-II RN advocates for patient care while ensuring compliance with industry-sponsored and investigator-initiated clinical trials, following FDA regulations and ICH/GCP guidelines.

Responsibilities

• Deliver safe care and demonstrate regard for the dignity and respect of all participants.
• Maintain clinical competencies including physical assessment, phlebotomy, and IV insertion.
• Practice the principles of Universal Precautions and abide by HIPAA regulations.
• Maintain a clean and prepared clinical space, performing set-up and turnover procedures according to SOPs.
• Participate in training programs to maintain licensure.
• Utilize positive interpersonal communication skills with healthcare team, patients, investigators, sponsors, and administration.
• Review informed consent documents according to regulations with study candidates or their legal representatives.
• Manage multiple clinical trial protocols, coordinate execution and follow-up, and perform accurate documentation.
• Promote Principal Investigator oversight by advising of deviations in conduct and patient status.
• Coordinate work of support staff, laboratory technicians, and assistants for efficient and high-quality results.
• Serve as liaison between Principal Investigators and the Institutional Review Board and Office of Sponsored Programs.
• Prepare and review documentation for clinical research study startup, execution, modification, renewal, and termination.
• Remain current on regulatory requirements and HIPAA regulations, implementing changes as needed.

Essential Skills

• Clinical research expertise
• Knowledge of Good Clinical Practice (GCP)
• Pre-screening patients
• Registered Nurse qualifications
• IV infusion skills
• Electronic Data Capture (EDC)
• Chart review proficiency

Additional Skills & Qualifications

• Associate degree in Nursing
• Minimum 2 years of Clinical Research experience
• Current active State of Florida license as a Registered Nurse
• Basic Life Support (BLS) certification

Work Environment

This position is based in a hospital setting, requiring adherence to clinical protocols and maintaining professionalism in a dynamic healthcare environment.