Research Nurse (TRI

Clinical Research Coordinator II RN / Research Nurse (TRI)

The Clinical Research Coordinator II RN (CRC-II RN) / Research Nurse plays a key role in planning, coordinating, evaluating, and delivering nursing care to participants enrolled in clinical research studies. Working under limited supervision, this role supports a research institute by managing industry-sponsored and investigator-initiated clinical trials, ensuring adherence to study protocols, FDA regulations, and ICH/GCP guidelines. The nurse advocates for participants' rights and safety, performs clinical procedures within scope of practice, and collaborates closely with principal investigators, sub-investigators, and the broader research team to collect high-quality data and maintain the integrity of each trial.

Responsibilities

• Plan, coordinate, evaluate, and provide nursing care to clinical research participants in accordance with study-specific protocol guidelines.
• Collect and document study data accurately, legibly, and in a timely manner for assigned research projects.
• Communicate effectively with principal investigators, sub-investigators, clinical research leads, support staff, and sponsors to ensure smooth study execution.
• Advocate for research participants by prioritizing their rights, safety, and well-being throughout the clinical trial process.
• Deliver safe, compassionate care that demonstrates respect and dignity for all participants.
• Perform clinical competencies including physical assessments, phlebotomy, IV insertion, and administration of investigational drugs within scope of practice and organizational policies.
• Practice Universal Precautions and adhere to HIPAA regulations to protect patient privacy and maintain confidentiality.
• Maintain a clean, prepared clinical space, performing set-up and turnover procedures in all clinical areas according to standard operating procedures.
• Review and explain all elements of the current IRB-approved informed consent document to study candidates and/or legal representatives, ensuring informed consent is understood and maintained as an ongoing process.
• Manage multiple clinical trial protocols simultaneously, coordinating execution, follow-up, and resource utilization while working independently.
• Handle study records, study medications, and test articles in a confidential, secure, and compliant manner.
• Promote investigator oversight by promptly advising principal investigators, sub-investigators, supervisors, and clinical operations leadership of protocol deviations, changes in patient status, and any issues affecting trial integrity or participant safety.
• Coordinate the work of support staff, laboratory technicians, and assistants to ensure efficient workflows, timely results, and adherence to research protocols.
• Assist physicians, clinical research nurses, and other team members with minor procedures and study-specific requirements within scope of practice.
• Participate in internal and external training programs to maintain licensure and stay current with clinical research and nursing best practices.
• Acclimate and integrate into various clinical settings as required by different research protocols, maintaining flexibility and professionalism.

Essential Skills

• Minimum 2 years of clinical research experience.
• Current, active State of Florida license as a Registered Nurse.
• Associate degree in Nursing.
• Basic Life Support (BLS) certification.
• Proficiency in clinical trial operations, including protocol adherence and data collection.
• Ability to perform physical assessments, phlebotomy, and IV insertion safely and effectively.
• Ability to administer investigational drugs in accordance with institutional policies and procedures.
• Knowledge of FDA regulations and ICH/GCP guidelines related to clinical research.
• Experience with informed consent processes and patient advocacy in a research setting.
• Strong interpersonal and communication skills for working with patients, investigators, sponsors, and multidisciplinary healthcare teams.
• Ability to manage multiple clinical trial protocols and work independently while maintaining high-quality documentation.
• Competence in practicing Universal Precautions and adhering to…