The Research Nurse II will be responsible for the coordination of the research studies and research participation within the department. The Research Nurse II has further responsibility to lead the research personnel, to include quality monitoring for patient safety and protocol compliance. The Research Nurse II will be involved in ensuring that any research undertaken within the department safeguards the well-being of the patients and is conducted within ICH Good Clinical Practice Guidelines for Research. In conjunction with the multidisciplinary team facilitate the production of good quality of research. The Research Nurse II will be instrumental in implementing team objectives to enhance the performance and development of the research nurses.

• Duties and responsibilities in the areas of:


• Clinical research coordination.  Collaborates with other healthcare providers to ensure continuity of study protocols and patient care.


• In collaboration with physician investigators, coordinates, delivers and monitors care to research participants throughout their participation.


• Assists physician investigators with screening and identification of potentially eligible patients.


• Delegated authority to conduct informed consent process.


• Timely, accurate and comprehensive documentation of all research activities, including informed consent.


• Participates in quality assurance initiatives to ensure research activities are in compliance


• To safeguard interest of patients by liaising with relevant personnel to ensure compliance with ICH GCP Guidelines.


• To ensure that all proposed research projects carried out in the department are reviewed by the Institutional Review Committee (IRB) prior to commencement and that updates and amendments are reported in a timely fashion.


• To provide advice and support to other members of the multidisciplinary team with regard to ICH and GCP, project development, implementation, completion and dissemination.


• To assess and evaluate the progress of on-going clinical trials and research undertaken in the unit.


• Maintaining an accurate account of the status of the projects and to regularly update the department on the status.


• Liaison with sponsors regarding feasibility and implementation aspects of proposed research studies.


• Liaison with the multidisciplinary team to promote and oversee the appropriate referral and recruitment of patients to research within the unit for which the post holder has a designated responsibility.


• Ensure that all ICH GCP required documentation is kept in a clearly trackable system and is stored for the appropriate time to ensure clear, accurate records, developing data collection, case report forms and design of database where required.


• To establish and maintain good working relationships with supporting clinical services.


• To establish and maintain good channels of communication with other departments within the Medical Center, other Medical Centers, non-commercial bodies and sponsors.


• In conjunction with, or in the absence of the Manager, monitors and plans in advance workload of the department ensuring it is adequately resourced.


• In conjunction with the lead clinician and/or Manager develops and updates a strategy for research conduct within the department.


• Clinical Service and Professional Responsibilities:


• To provide ongoing advice and information to patients/members regarding their participation in clinical research in order to facilitate effective informed consent.


• To assist the clinicians in the assessment of patients/volunteers for eligibility for research and monitoring of their condition throughout their participation.


• To document patient/study results using KPSC information system and applications.  Communicates patient/protocol results on an ongoing basis to research team.


• To observe the confidentiality of patient information at all times in accordance with the Data Protection Act.


• To be conversant with and adhere to all clinical protocols.


• To work as part of the multidisciplinary team and contribute to the ongoing development of research within the department.


• To works within the scope of professional nursing conduct.


• To be responsible for developing and sustaining own knowledge, clinical skills and professional awareness in accordance with KP policies.


• Due regard must be given for the sexual orientation, age, customs, values and spiritual beliefs of patients in accordance with Equal Opportunities practices.


• To adhere to KPSC Policies, guidelines and current legislation including Health and Safety, Equal Opportunities and the No smoking policy.


• Personal Education, Training and Development:


• To keep up to date with departmental, FDA, ICH and state regulation developments for the management of clinical research ensuring timely, effective implementation of changes.


• To keep up to date with current and potential research and information relevant to the care of patients in the clinical area.


• To attend courses as deemed relevant and to attend meetings and conferences as appropriate.


• Prepare results of research and present as posters or scientific presentations at meetings and conferences as appropriate.


• Staff Management and Development:


• To act as a leader, resource and role model.


• May be responsible for the supervision, mentoring, training of other research nurses and junior staff including Research Associates.


• May provide feedback and evaluation as applicable.


• To facilitate and maintain effective communication within the research team.


• Travel:


• Position may require travel; onsite and/or remote patient care coverage across treatment locations may be required.