Registered Nurse (RN) - Medical Specialties - Research

Overview

Clinical Research Nurse II performs a full range of clinical and non-clinical research duties, and has a working knowledge of the clinical research process and the regulations that govern it. As licensed professionals with clinical research experience, they perform patient related care independently, including medical assessments, symptom management, and referrals, within the scope of their licensure. With the oversight of the PI or their designee, they perform progressively more complex and comprehensive clinical research duties at an ever-increasing level of independence, working closely with the Principal Investigator (PI). They work under supervision, but with more autonomy than an entry level position.

Responsibilities

Research Operations

Provide patient care to inpatients and outpatients receiving investigational therapy, occasionally requiring tasks outside of standard operating hours.

Screen and recruit potential research participants, verify eligibility and ensure enrollment requirements are met

Educate patient and family regarding investigational therapy in collaboration with the medical team

Ensure that patients are scheduled for all study assessments as required per research protocol

Prepare and administer all medications required per research protocol, including investigational and standard of care agents

Evaluate research patients for drug and/or disease-related toxicities and contribute to development of symptom management plans

Coordinate with the research team to address patient care delivery issues and quality improvement efforts

Ethics & Participant Safety

Maintain Good Clinical Practice (GCP)/Human Subjects Protection (HSP) practices

Articulate the rationale for individual protocols and their inclusion and exclusion criteria

Serve as a resource to ensure staff and patients recognize the difference between 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 trains others to these standards

Assist with data entry as needed

Contribute to the development of data collection documents and instruments

Detect issues related to data capture, collection or management; suggest solutions

Investigate incomplete or inaccurate documents to ensure completeness of data.

Assist with development of SOPs for data quality assurance.

Adhere to processes and run queries, summaries, and reports to monitor the quality of data

Utilizes required processes, policies, and systems to ensure data security

Leadership and Professionalism

Adheres to professional guidelines and code of ethics related to the conduct of clinical research

Mentor and train new and current clinical research staff in departmental research and administrative procedures

Support efforts to maintain an adequate number of competent staff to conduct clinical research in compliance with all regulatory, institutional and departmental requirements

Site and Study Management

May support site selection, feasibility, and study start up processes

Assist in the initiation, management, and completion of clinical trials and research studies

Encourage standardization of processes and procedures.

Implement a plan to ensure a safe, clean, and secure environment of care for patients, visitors, and staff

Perform other duties as assigned, such as supporting regulatory affairs

Communication and Team Science

Collaborate with and educate healthcare professionals regarding investigational research protocols

Ensure research compliance and adherence to protocol guidelines

Portfolio and Program Development & Management

May participate in committees or working groups to strengthen research implementation and practice

Clinical Skills

Ensure a safe, effective, and efficient patient care environment

Facilitate and monitor activities related to the delivery of patient care within research

Perform other duties as assigned.

Qualifications

• Graduate from an accredited nursing school required
• Bachelor of Science in Nursing preferred. Must be obtained within 3 years of hire.
• Minimum of 2 years of experience in Clinical Research required
• 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
• 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