Position Summary / Career Interest:

The Clinical Research Nurse Specialist is a licensed registered professional nurse who is a clinical expert and provides ethical, evidenced-based, safe and compassionate nursing care.  The RN-Clinical Research Specialist focuses on protocol analysis, review, and compliance by educating staff and collaborating with interdisciplinary team members to create nursing resources for execution of study deliverables. The RN-Clinical Research Specialist is familiar with The University of Kansas Health System clinical and research policies and procedures. The RN-Clinical Research Specialist collaborates with providers, nursing leadership, registered nurses, clinical research coordinators, research lab coordinators, and study sponsors to ensure best practice and adherence to Health System policies and procedures and research protocols. The RN-Clinical Research Specialist supports and adheres to The University of Kansas Hospital Code of Ethics and Business Standards. 

Responsibilities and Essential Job Functions

• Collaborate with investigators, practitioners, coordinators, sponsors, and nursing leaders to review and prepare for upcoming clinical trials.
• Review and analyze potential trial protocols to determine site feasibility and readiness during study startup, including a thorough evaluation of nursing activities, to identify any potential barriers for compliance or conflicts with SOPs.
• Collaborate with research coordinators to create and maintain nursing order sets to ensure protocol compliance.
• Collaborate with research lab staff to create and maintain nursing tip sheets and flowsheets to ensure protocol compliance.
• Collaborates with nursing leadership, research coordinators, and other departments within the Health System to create workflows for completing protocol-required assessments outside of the Clinical Research Center.
• Review treatment Beacon plans prior to study activation to ensure protocol compliance and accuracy for nursing.
• Attend trial-related meetings with sponsors, investigators, and practitioners.
• Represent nursing at Disease Working Group meetings to support the safety of the patients and staff and to ensure research protocol deliverables are feasible at the research site.
• Provide education and training to staff regarding newly approved and amended existing clinical trials.
• Review and analyze protocol amendments. Review and update nursing orders, tip sheets, and flowsheets as needed based on amendments.
• Promotes open and effective communication among practitioners, nursing, research teams, and other departments.
• Ensure the welfare and safety of all patients participating in clinical trials are protected, and that all legal, privacy and confidentiality protection measures are implemented.
• Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Coordinate with sponsor, Research Institute, IRB, or FDA as necessary to support studies.
• Must be able to perform the professional, clinical and or technical competencies of the assigned unit or department.
• These statements are intended to describe the essential functions of the job and are not intended to be an exhaustive list of all responsibilities. Skills and duties may vary dependent upon your department or unit. Other duties may be assigned as required.

Required Education and Experience

• Bachelor Degree Nursing in Nursing Registered Nurse

Preferred Education and Experience

• Hematology/Oncology Nursing Experience
• 2 or more years Relevant Clinical Research Nursing

Required Licensure and Certification

• Licensed Registered Nurse (LRN) - Multi-State - State Board of Nursing
• Basic Cardiac Life Support (BLS or BCLS) - American Heart Association (AHA)
• Complete and maintain training in Human Subject Protection, GCP, HIPPA and the Informed Consent process within 60 Days
• Chemo Certification - Oncology Nursing Society (ONS) Chemotherapy and Biotherapy within 1 Year

Knowledge Requirements

• Excellent analytical, critical thinking and problem-solving skills
• Read and comprehend complex clinical trial protocols and make recommendations for consideration including site selection and resource impact
• Knowledge of clinical trial development and regulatory process preferred
• Ability to engage in self-directed education and development and work independently
• Complete and maintain training in Human Subjects Protection, GCP, HIPAA, and the informed consent process required
• Create tools and education for nursing teams executing the clinical trial
• Basic typing and word processing ability

We are an equal employment opportunity employer without regard to a person’s race, color, religion, sex (including pregnancy, gender identity and sexual orientation), national origin, ancestry, age (40 or older), disability, veteran status or genetic information.