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.

1. Research Operations

   1. Provide patient care to inpatients and outpatients receiving investigational therapy, occasionally requiring tasks outside of standard operating hours.
   2. Screen and recruit potential research participants, verify eligibility, and ensure enrollment requirements are met.
   3. Educate patient and family regarding investigational therapy in collaboration with the medical team
   4. 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 5. of care agents

   6. Evaluate research patients for drug and/or disease-related toxicities and contribute to development of symptom management plans
   7. Coordinate with the research team to address patient care delivery issues and quality improvement efforts

   Ethics & Participant Safety

   1. Maintain Good Clinical Practice (GCP)/Human Subjects Protection (HSP) practices
   2. Articulate the rationale for individual protocols and their inclusion and exclusion criteria
   3. 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

   1. Utilize electronic systems, technologies, and software necessary for study operations
   2. Accurately document study visit assessments for data collection and trains others to these standards
   3. Assist with data entry as needed
   4. Contribute to the development of data collection documents and instruments
   5. Detect issues related to data capture, collection or management; suggest solutions
   6. Investigate incomplete or inaccurate documents to ensure completeness of data.
   7. Assist with development of SOPs for data quality assurance.
   8. Adhere to processes and run queries, summaries, and reports to monitor the quality of data
   9. Utilizes required processes, policies, and systems to ensure data security

   Leadership and Professionalism

   1. Adheres to professional guidelines and code of ethics related to the conduct of clinical research
   2. Mentor and train new and current clinical research staff in departmental research and administrative procedures
   3. 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

   1. May support site selection, feasibility, and study start up processes
   2. Assist in the initiation, management, and completion of clinical trials and research studies
   3. Encourage standardization of processes and procedures.
   4. Implement a plan to ensure a safe, clean, and secure environment of care for patients, visitors, and staff
   5. Perform other duties as assigned, such as supporting regulatory affairs

   Communication and Team Science

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

   Portfolio and Program Development & Management

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

   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

   Perform other duties as assigned.

• 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

• RN licensure in the appropriate state of practice required
• Basic Life Support (BLS) certification required