Registered Nurse III (RN) - Clinical Research Units

OverviewClinical Research UnitsThe Clinical Research Nurse III performs comprehensive research duties at an advanced level, focusing on the overall productivity and success of clinical trials.

This role requires strong working knowledge of the clinical research process and the regulations that govern it. As a licensed professional with research experience, they perform patient related care independently, within the scope of licensure.

Requiring minimal oversight, they will often support less experienced research nurses and support staff. They are active participants in decision making, and contribute to the overall planning and organization of research practices.

Responsibilities* Research Operations* Provide patient care to inpatients and outpatients receiving investigational therapy, occasionally requiring completion of tasks outside of standard operating hours* Screen and recruit potential research participants.

• Highly involved in eligibility verification and ensures enrollment requirements are met.* Educate patient and family 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 of care agents* Evaluate research patients for drug and / or disease-related toxicities and manages symptoms* Coordinate with the research team to address patient care delivery issues and quality improvement efforts* Ethics & Participant Safety* Adheres to Good Clinical Practice (GCP) / Human Subjects Protection (HSP) guidelines and maintain current training* Serve as an expert resource to study teams as they design studies and conduct clinical trials, to ensure ethical conduct and protection of vulnerable populations* 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 management of clinical research participants* Contribute to the development of policies and procedures to maintain patient and staff safety* Data and Informatics* Proficient in the use of electronic systems, technologies, and software necessary for study operations, and trains others* Accurately documents study visit assessments for data collection and ensures others are meeting these standards* Assists with data entry as needed* Contribute to the development of data collection documents and instruments* Monitor for and detect issues related to data capture, collection or management;
• suggest solutions* Investigate incomplete or inaccurate documents to ensure completeness of data; and develop, or assists with development of, SOPs for data quality assurance* Adhere to processes and run queries, summaries, and reports to monitor the quality of data* Identify trends related to data quality and escalating as appropriate* Utilize required processes, policies, and systems to ensure data security* Recognize and reports vulnerabilities related to security of physical and electronic data;

suggest and implement solutions to vulnerabilities related to security of data and data provenance* Scientific Concepts and Research Designs* Assess operational shortcomings of proposals and protocols and contributes to solutions* Leadership and Professionalism* Mentor and train new and current clinical research staff in departmental research and administrative procedures* Provide support to entry level staff* Support efforts to recruit competent staff to conduct clinical research in compliance with all regulatory, institutional and departmental requirements, participate in the interview process* Site and Study Management* Support site selection, feasibility, and study start up processes* Provide expertise in the initiation, management, and completion of clinical trials and research studies* Develop research nurse time estimates to provide the Clinical Trials Office for budget negotiations.

• Assist in the development of, and encourages standardization of processes and procedures* Develop and implements 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* Collaborates with and educates healthcare professionals regarding investigational research protocols* Ensure research compliance and adherence to protocol guidelines* Portfolio and Program Development & Management Monitor a portfolio of clinical trials and provide required reports to administration* Participate in committees and 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 researchPerform other duties as assignedQualifications* Graduate from accredited nursing school required* Bachelor of Science in Nursing required* Minimum of 4 years of experience in Clinical Research* Minimum of 2 years clinical nursing experience required* Excellent interpersonal and communication skills required* Excellent attention to detail requiredRequired Licensure / Certifications* RN licensure in the appropriate state of practice required* Specialty certifications considered with approval of Office of Research Operations Nursing leadership* Basic Life Support (BLS) certification required* Good Clinical Practice (GCP) / Human Subjects Protection (HSP) certification required* SOCRA / ACRP certification required
3 days ago