Job Summary: The Clinical Research Nurse is responsible for assisting in the execution of clinical research studies under the direction of the principal investigator or research team. This role involves coordinating with various stakeholders, including patients, physicians, and regulatory agencies, to ensure the successful conduct of research protocols. The Clinical Research Nurse is also responsible for maintaining accurate records, collecting data, and ensuring compliance with ethical and regulatory guidelines.

Key Responsibilities:

1. Protocol Implementation: Assist in the development and implementation of research protocols, including patient recruitment, screening, and enrollment.
2. Patient Care: Provide nursing care to research participants, including administering investigational drugs, monitoring vital signs, and managing adverse events.
3. Data Collection and Management: Collect and record research data accurately, ensuring compliance with data collection procedures and regulatory requirements. Maintain confidentiality of participant information.
4. Coordination: Coordinate study visits, laboratory tests, and other procedures required by the research protocol. Collaborate with other healthcare professionals and research staff to ensure smooth study operations.
5. Regulatory Compliance: Ensure compliance with institutional policies, federal regulations (e.g., Good Clinical Practice guidelines), and ethical standards governing human subjects research.
6. Participant Education: Educate research participants about study procedures, potential risks, and benefits. Obtain informed consent from participants according to regulatory guidelines.
7. Documentation: Maintain comprehensive and accurate documentation of study activities, including case report forms, study logs, and regulatory submissions.
8. Safety Monitoring: Monitor participants for adverse events and report any safety concerns to the principal investigator and appropriate regulatory authorities.
9. Quality Assurance: Assist in quality assurance activities, including monitoring and auditing of study procedures to ensure adherence to protocol and regulatory requirements.
10. Training: Participate in ongoing training and professional development activities to stay updated on research protocols, regulatory changes, and best practices in clinical research.

Qualifications:

1. Bachelor's degree in Nursing (BSN) from an accredited institution. 
2. Current RN license in the state of Tennessee.
3. Experience starting an IV.
4. Experience drawing blood.
5. Clinical research experience preferred, including knowledge of research methodologies, regulatory requirements, and Good Clinical Practice guidelines.
6. Strong communication and interpersonal skills, with the ability to interact effectively with diverse stakeholders.
7. Attention to detail and strong organizational skills.
8. Ability to work independently and as part of a multidisciplinary team.
9. Certification in clinical research (e.g., CCRC, CCRP) preferred.