Advanced Clinical Research Nurse
2 weeks ago
Clinical Research Operations
The Advanced Clinical Research Nurse plays a pivotal role in conducting extensive research activities at a sophisticated level, emphasizing the efficacy and success of clinical trials. This position necessitates a robust understanding of the clinical research framework and the associated regulations. As a licensed professional with substantial research expertise, the nurse provides patient care autonomously, adhering to licensure boundaries. With minimal supervision, they often mentor junior research nurses and support personnel. They actively engage in decision-making processes and contribute to the strategic planning and organization of research methodologies.
Key Responsibilities
- Research Operations
- Deliver patient care to both inpatients and outpatients undergoing investigational treatments, occasionally necessitating tasks beyond standard operating hours.
- Identify and recruit potential research subjects, playing a significant role in eligibility assessments and ensuring compliance with enrollment criteria.
- Inform patients and their families about investigational treatments in collaboration with the medical team.
- Ensure timely scheduling of all study evaluations as dictated by research protocols.
- Prepare and administer medications as required by research protocols, including both investigational and standard care agents.
- Assess research participants for drug and/or disease-related adverse effects and manage symptoms accordingly.
- Collaborate with the research team to resolve patient care delivery challenges and enhance quality improvement initiatives.
- Ethics & Participant Safety
- Comply with Good Clinical Practice (GCP) and Human Subjects Protection (HSP) guidelines, maintaining up-to-date training.
- Act as a knowledgeable resource for study teams during the design and execution of clinical trials, ensuring ethical practices and safeguarding vulnerable populations.
- Clearly communicate the rationale behind individual protocols and their inclusion/exclusion criteria.
- Serve as a resource to clarify the distinction between clinical care management and the management of clinical research participants.
- Contribute to the formulation of policies and procedures aimed at ensuring the safety of patients and staff.
- Data Management and Informatics
- Demonstrate proficiency in utilizing electronic systems, technologies, and software essential for study operations, while training others.
- Accurately document study visit evaluations for data collection and ensure compliance with these standards by others.
- Assist with data entry as necessary.
- Contribute to the creation of data collection documents and instruments.
- Monitor and identify issues related to data capture, collection, or management; propose solutions.
- Investigate incomplete or erroneous documents to guarantee data completeness; assist in developing Standard Operating Procedures (SOPs) for data quality assurance.
- Follow established processes and generate queries, summaries, and reports to oversee data quality.
- Identify trends related to data quality and escalate concerns as appropriate.
- Utilize required processes, policies, and systems to safeguard data security.
- Recognize and report vulnerabilities concerning the security of physical and electronic data; propose and implement solutions to mitigate these vulnerabilities.
- Scientific Concepts and Research Designs
- Evaluate operational deficiencies in proposals and protocols, contributing to remedial solutions.
- Leadership and Professionalism
- Mentor and train both new and existing clinical research personnel in departmental research and administrative protocols.
- Provide support to entry-level staff.
- Assist in recruiting qualified personnel to conduct clinical research in accordance with all regulatory, institutional, and departmental guidelines, participating in the interview process.
- Site and Study Management
- Aid in site selection, feasibility assessments, and study initiation processes.
- Offer expertise in the initiation, management, and conclusion of clinical trials and research studies.
- Develop time estimates for research nurses to facilitate budget negotiations with the Clinical Trials Office.
- Assist in the development of, and promote standardization of, processes and procedures.
- Formulate and implement plans to ensure a safe, clean, and secure care environment for patients, visitors, and staff.
- Perform additional duties as assigned, including support for regulatory affairs.
- Communication and Team Collaboration
- Collaborate with and educate healthcare professionals regarding investigational research protocols.
- Ensure compliance with research protocols and adherence to guidelines.
- Portfolio and Program Development & Management
- Oversee a portfolio of clinical trials and provide necessary reports to administration.
- Participate in committees and working groups to enhance 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 settings.
- Graduate from an accredited nursing program required.
- Bachelor of Science in Nursing required.
- Minimum of 4 years of experience in Clinical Research.
- Minimum of 2 years of clinical nursing experience required.
- Exceptional interpersonal and communication skills required.
- Strong attention to detail required.
- RN licensure in the relevant state of practice required.
- Specialty certifications considered with approval from Nursing leadership.
- Basic Life Support (BLS) certification required.
- Good Clinical Practice (GCP) and Human Subjects Protection (HSP) certification required.
- SOCRA/ACRP certification required.
- Area of Interest: Nursing;
- FTE/Hours per pay period: hrs/week;
- Shift: Day;
- Job ID: 24884;
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