Clinical Research Nurse II
4 weeks ago
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
- 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 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.
- Prepare and administer all medications required per research protocol, including investigational and standard agents of care.
- Evaluate research patients for drug- and/or disease-related toxicities and contribute to the development of symptom management plans.
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 train 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 the development of SOPs for data quality assurance.
- Adhere to processes and run queries, summaries, and reports to monitor the quality of data.
- Utilize required processes, policies, and systems to ensure data security.
Leadership and Professionalism
- Adhere 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
- Minimum of 2 years of clinical nursing experience required.
- Excellent interpersonal and communication skills required.
- Excellent attention to detail required.
- Minimum of 2 years of experience in Clinical Research required.
- Bachelor of Science in Nursing preferred. Must be obtained within 3 years of hire.
- Graduate from an accredited nursing school required.
Required Licensure/Certifications
- RN licensure in the appropriate state of practice required.
- Basic Life Support (BLS) certification required.
- SOCRA/ACRP certification preferred. Must be obtained within 1 year of hire.
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