Job Description

Overview

The Clinical Research Nurse I performs a variety of clinical and non-clinical tasks associated with conducting clinical research, and within the scope of licensure. Working closely with research participants and their families, they provide care, education and support throughout the trial. Under the supervision of the PI or their designee, this position collaborates with research and non-research staff, maintaining involvement throughout the clinical trial process. The role of the Clinical Research Nurse I is introductory, with assignments provided at a task level, and focused on less complex clinical research trials and processes.

Responsibilities

Research Operations

1. Provide patient care to inpatients and outpatients receiving investigational therapy
2. Screen and recruit potential research participants and assist with verification of inclusion and exclusion criteria for eligibility purposes
3. Assist with educating patients and families regarding investigational therapy in collaboration with the medical team
4. Ensure that patients are scheduled for all study assessments as required per research protocol
5. Assist with the preparation and administration of all medications required per research protocol, including investigational and standard of care agents
6. Assist with the evaluation and management of research patients for drug and/or disease-related toxicities and symptoms

Ethics & Participant Safety:

1. Adhere to and maintain Good Clinical Practice (GCP)/Human Subjects Protection (HSP) practices and required training
2. Articulate the rationale for individual protocols
3. Serve as a resource to ensure staff and patients recognize the difference between routine clinical care management and care management of clinical research participants

Data and Informatics

1. Utilize electronic systems, technologies, and software necessary for study operations
2. Accurately document study visit assessments for data collection And assist with data entry as needed
3. Assist with the development of, data collection documents and instruments
4. Adhere to required processes, policies, and systems protocols to ensure data security

Leadership and Professionalism

1. Follow professional guidelines and code of ethics related to the conduct of clinical research.

Site and Study Management

1. Assist in the initiation, management, and completion of clinical trials and research studies.
2. Perform other duties as assigned, such as supporting regulatory affairs

Communication and Team

1. Collaborate with and educates healthcare professionals regarding investigational research protocols
2. Ensure research compliance and adherence to protocol guidelines

Clinical Skills

1. Ensure a safe, effective, and efficient patient care environment
2. Facilitate and monitor activities related to the delivery of patient care within research
3. Other duties as assigned

Qualifications

• Graduate from an accredited nursing school required.
• Bachelor of Science in Nursing preferred. Must be obtained within 4 years of hire
• Previous knowledge of research preferred
• Minimum of 2 years clinical nursing experience required
• Excellent interpersonal and communication skills required
• Excellent attention to detail required

Required Licensure/Certifications

• Licensed RN with NH eligibility
• Certified Good Clinical Practice (CGCP) within 30 days; Human Subjects Protection (HSP) certification within 30 days
• BLS

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