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