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
Provide patient care to inpatients and outpatients receiving investigational therapy
Screen and recruit potential research participants and assist with verification of inclusion and exclusion criteria for eligibility purposes
Assist with educating patients and families regarding investigational therapy in collaboration with the medical team
Ensure that patients are scheduled for all study assessments as required per research protocol
Assist with the preparation and administration of all medications required per research protocol, including investigational and standard of care agents
Assist with the evaluation and management of research patients for drug and/or disease-related toxicities and symptoms
Ethics & Participant Safety:
Adhere to and maintain Good Clinical Practice (GCP)/Human Subjects Protection (HSP) practices and required training
Articulate the rationale for individual protocols
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
Utilize electronic systems, technologies, and software necessary for study operations
Accurately document study visit assessments for data collection And assist with data entry as needed
Assist with the development of, data collection documents and instruments
Adhere to required processes, policies, and systems protocols to ensure data security
Leadership and Professionalism
Follow professional guidelines and code of ethics related to the conduct of clinical research.
Site and Study Management
Assist in the initiation, management, and completion of clinical trials and research studies.
Perform other duties as assigned, such as supporting regulatory affairs
Communication and Team
Collaborate with and educates healthcare professionals regarding investigational research protocols
Ensure research compliance and adherence to protocol guidelines
Clinical Skills
Ensure a safe, effective, and efficient patient care environment
Facilitate and monitor activities related to the delivery of patient care within research
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 Registered Nurse with NH Eligibility
- Basic Life Support (BLS) certification required
- Certified Good Clinical Practice (CGCP) within 30 days
- Human Subjects Protection (HSP) within 30 days
- Responsible Conduct in Research (RCR) within 30 days