Responsible for providing nursing support to clinical trials and performing necessary procedures at times
required by the clinical trial protocol. Collaborates with practitioners, nursing leadership, registered nurses,
and clinical trial coordinators. Supports and adheres to The University of Kansas Hospital Code of Ethics and Business Standards
1) Must be able to perform the professional, clinical and or technical competencies of the assigned unit or department.
2) Collaborate with investigators, coordinators, and nursing leaders to review and prepare for upcoming clinical trials. Assist in providing education and training to staff regarding new and existing clinical trials.
3) Coordinates and performs study events in accordance with clinical trial protocols, balancing trial requirements with patient needs. May disburse investigational drugs/devices and provide patient education regarding administration.
4) Ensuring that the welfare and safety of all patients participating in clinical trials are protected, and that all legal, privacy and confidentiality protection measures are implemented.
5) Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
6) Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
7) May oversee the preparation of orders by practitioners to assure that protocol compliance is maintained. Communicates with practitioners and primary study coordinators regarding study requirements, need for modifications, and adverse event reporting.
8) Provides nursing support to clinical trial activities taking place in assigned units and care areas. Performs procedures and activities as authorized by hospital policy and called for by study protocols.
9) Responsible for accurate and timely data collection, documentation, and reporting of all procedures to primary study coordinator for data entry.
• Associate's Degree in Nursing (or higher degree) required
• Must complete BSN within five years of hire as RN
• American Heart Association basic life support (BLS) or an American Red Cross CPR for the Professional Rescuer certification
• Current RN license in Kansas required
• Minimum of two years RN experience required
• Ability to engage in self-directed education and development required
• Complete and maintain training in Human Subjects Protection, GCP, HIPAA, and the informed consent process required