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Description
The Clinical Research Nurse is responsible for performing protocol-required nursing and clinical procedures for assigned research studies. This role works in close collaboration with the Principal Investigator, Sub-Investigators, and Clinical Research Coordinators to ensure subject safety, high-quality clinical execution, and compliance with study protocols and regulatory standards.
The Clinical Research Nurse serves as the primary owner of licensed nursing care, clinical assessments, phlebotomy, infusion administration, and patient monitoring within clinical trials.
Key Responsibilities
Study & Protocol Knowledge
- Maintain thorough knowledge of assigned studies through protocol review, investigator meetings, start-up meetings, and collaboration with the Principal Investigator.
- Adhere strictly to study protocols, GCP, and regulatory requirements.
- Obtain protocol exemptions or deviations when appropriate and approved.
Clinical & Nursing Procedures
- Perform protocol-required nursing and clinical procedures, including but not limited to:
o Vital signs, height, and weight
o ECGs
o Phlebotomy and specimen collection
o Preparation, administration, and monitoring of infusions, as required by protocol and within scope of licensure
o Specimen processing, packaging, and shipment
- Monitor subjects before, during, and after procedures to ensure safety and protocol compliance.
- Dispense investigational products and maintain accurate administration documentation, as applicable.
Patient Assessment & Safety
- Collect initial and ongoing medical and psychiatric information through patient interviews and record review.
- Assess and monitor adverse events and clinical changes.
- Escalate safety concerns and clinical issues to the Principal Investigator and study team promptly.
Patient Education & Support
- Educate patients and families regarding study participation, investigational products, and clinical trial processes.
- Ensure patient understanding of procedures, risks, and expectations.
- Provide appropriate community referrals at the conclusion of study participation.
Communication & Collaboration
- Maintain clear communication with patients, investigators, CRCs, sponsors, CROs, monitors, and auditors.
- Participate in meetings and calls related to clinical execution.
- Support multi-site collaboration when applicable.
Documentation & Data Integrity
- Maintain timely, accurate clinical source documentation.
- Support monitor visits and respond to clinical clari?cation requests.
- Ensure documentation meets protocol, sponsor, and regulatory standards.
Additional Responsibilities
This job description outlines the primary responsibilities of the Clinical Research Nurse but is not intended to be exhaustive. Responsibilities may expand based on protocol requirements, clinic operations, and organizational needs. Flexibility and collaboration are essential to success in this role.
Requirements
Knowledge, Skills, and Abilities
- Strong verbal and written communication skills
- Excellent interpersonal and patient-care skills
- Ability to work effectively in a fast-paced, multi-office environment
- Strong organizational and multitasking abilities
- High attention to detail and commitment to patient safety
- Ability to maintain con?dentiality
- Pro?ciency with clinical and office equipment
- Demonstrated competency in phlebotomy and infusion procedures
Required Experience & Quali?cations
- Education: Bachelor's degree required
- Licensure: Active Registered Nurse (RN) license required
- Experience: Prior experience as a Clinical Research Coordinator, Research Assistant, or Clinical Research Nurse preferred
- Clinical Skills: Phlebotomy and infusion experience required