Clinical Research Nurse II
4 days ago
Job Summary:
The Clinical Research Nurse II is a key member of our research team, responsible for providing high-quality patient care and conducting clinical research duties with minimal supervision. This role requires a strong understanding of the clinical research process and regulations, as well as excellent communication and interpersonal skills.
Key Responsibilities:- Provide patient care to inpatients and outpatients receiving investigational therapy, including 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 patients are scheduled for all study assessments as required per research protocol.
- Prepare and administer medications required per research protocol, including investigational and standard care agents.
- Evaluate research patients for drug and/or disease-related toxicities and contribute to the development of symptom management plans.
- Coordinate with the research team to address patient care delivery issues and quality improvement efforts.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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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