Advanced Clinical Research Nurse
2 weeks ago
Clinical Research Operations
The Advanced Clinical Research Nurse plays a pivotal role in executing extensive research responsibilities at a high level, emphasizing the efficiency and success of clinical trials. This position demands a robust understanding of the clinical research framework and the associated regulations. As a licensed nursing professional with significant research expertise, the nurse provides patient-centered care autonomously, adhering to the limits of their licensure. With minimal supervision, they often mentor less experienced 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 Management
- Deliver patient care to both inpatients and outpatients involved in investigational treatments, which may occasionally require tasks beyond standard operating hours.
- Identify and recruit potential research participants, playing a crucial role in eligibility assessment and ensuring compliance with enrollment criteria.
- Provide education to patients and their families regarding investigational treatments in collaboration with the healthcare team.
- Ensure that patients are scheduled for all necessary study evaluations as mandated by the research protocol.
- Prepare and administer medications as required by the research protocol, including both investigational and standard care medications.
- Assess research participants for drug-related or disease-related adverse effects and manage associated symptoms.
- Collaborate with the research team to address patient care delivery challenges and enhance quality improvement initiatives.
- Ethics and Participant Welfare
- Comply with Good Clinical Practice (GCP) and Human Subjects Protection (HSP) standards, maintaining current training.
- Act as a knowledgeable resource for study teams during the design and execution of clinical trials, ensuring ethical practices and the protection of vulnerable populations.
- Clearly communicate the rationale behind individual protocols and their respective inclusion and exclusion criteria.
- Serve as a guide to ensure that staff and patients understand the distinction between clinical care management and the management of clinical research participants.
- Contribute to the formulation of policies and procedures aimed at safeguarding patient and staff welfare.
- Data Management and Informatics
- Demonstrate proficiency in utilizing electronic systems, technologies, and software essential for study operations, while also training others.
- Accurately document study visit evaluations for data collection and ensure compliance with established standards by others.
- Assist with data entry as required.
- Participate in the development of data collection tools and instruments.
- Monitor and identify issues related to data capture, collection, or management, proposing solutions as necessary.
- Investigate incomplete or erroneous documents to ensure data integrity and 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 concerning data quality and escalate issues as appropriate.
- Employ required processes, policies, and systems to guarantee data security.
- Recognize and report vulnerabilities related to the security of both physical and electronic data, proposing and implementing solutions to address these vulnerabilities.
- Scientific Concepts and Research Design
- Evaluate operational deficiencies in proposals and protocols, contributing to viable solutions.
- Leadership and Professional Development
- Mentor and train new and existing clinical research personnel in departmental research and administrative protocols.
- Provide guidance to entry-level staff.
- Support initiatives to recruit qualified personnel for conducting clinical research in compliance with all regulatory, institutional, and departmental standards, and participate in the hiring process.
- Site and Study Coordination
- Assist in site selection, feasibility assessments, and the initiation of studies.
- Offer expertise in the initiation, management, and conclusion of clinical trials and research studies.
- Develop time estimates for research nursing activities to aid the Clinical Trials Office in budget discussions.
- Help establish 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 Collaborative Science
- Work collaboratively with and educate healthcare professionals regarding investigational research protocols.
- Ensure compliance with research protocols and adherence to guidelines.
- Portfolio and Program Oversight
- Monitor a portfolio of clinical trials and provide necessary reports to administration.
- Engage in committees and working groups to enhance research implementation and practice.
- Clinical Proficiencies
- Ensure a safe, effective, and efficient patient care environment.
- Facilitate and oversee activities related to the delivery of patient care within the research context.
- Graduate from an accredited nursing program is required.
- Bachelor of Science in Nursing is required.
- A minimum of 4 years of experience in Clinical Research is required.
- At least 2 years of clinical nursing experience is required.
- Exceptional interpersonal and communication skills are essential.
- Strong attention to detail is required.
- RN licensure in the relevant state of practice is required.
- Specialty certifications may be considered with approval from Nursing leadership in the Office of Research Operations.
- Basic Life Support (BLS) certification is required.
- Good Clinical Practice (GCP) and Human Subjects Protection (HSP) certification is required.
- SOCRA/ACRP certification is required.
- Area of Interest: Nursing;
- FTE/Hours per pay period: hrs/week;
- Shift: Day;
- Job ID: 24884;
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