Research Nurse RN - Clinical Trials

Department Overview

The Research Nurse is responsible for the clinical research activities for cardiomyopathy clinical research studies conducted at the OHSU Knight Cardiovascular Institute in the Department of Cardiology. The Research Nurse works collaboratively with other staff and provides services, as assigned by the clinical trials leadership team and/or the cardiomyopathy section head, in furtherance of the university’s mission and goals. The primary objectives of this position are to recruit, screen, monitor and document the subjects’ responses to clinical trial interventions. The Research Nurse provides monitoring and clinical expertise to ensure protocol adherence and accurate data collection. The Research Nurse will be responsible for administering investigational products through different routes including intravenous infusions, and in certain cases gene therapy or gene editing investigational products. In addition to direct research responsibilities, the individual in this position is responsible for mentoring OHSU or affiliate site staff members, and identifying opportunities for and implementing process improvement.

 

The research nurse will have a very strong understanding of research regulations, reporting requirements, and EMR documentation for research purposes. This position will primarily support our Hypertrophic Cardiomyopathy research team within the division of Cardiology, they may be reassigned secondary duties to support other sections within the Cardiovascular Medicine Clinical Trials Unit and Knight Cardiovascular Institute.

Function/Duties of Position

Always promotes the mission of the Knight Cardiovascular Institute through our Professional Standards of timely Customer Service, Reliability, Productivity, Professionalism, Accuracy, Timeliness, Integrity, and Problem-Solving. 

 

Clinical Responsibilities:

• Oversees and assists in providing and assuring the highest standard of care for subjects involved in clinical trials at the OHSU Knight Cardiovascular Institute within the department of Cardiology.
• Initiates protocol screening and verifies eligibility for identified patients. Participates in the informed consent process through provision of detailed patient and family information of the appropriate protocol.
• Functions as a primary nurse for specific study population(s). Under the direction of a credentialed provider, the research nurse is responsible for evaluating current diagnosis information, ordering diagnostic tests and study medications to ensure protocol adherence, therapeutic interventions, sample acquisition, documentation of variances, ensuring appropriate billing process, and completion of accurate data collection.
• Provides telephone triage for lab/symptoms assessment, information, therapeutic intervention, and appropriate MD follow-up for protocol patients.
• Performs specific procedures appropriate to patient population including but not limited to venipunctures.
• Reinforces patient and family information regarding treatment options, specific drug administration, test/procedure aspects, and expected toxicity management.
• Coordinates the dispensing of study medications in accordance with specific protocol.
• Responsible for administering investigational products through different routes according to the respective protocol and in adherence with local policies. 
• Collaborates with nursing colleagues, and other members of the health care team, to insure smooth transitions and optimal patient care management.
• Reports adverse events in a timely fashion as required by specific clinical trial and by federal regulations.
• Facilitates development of study coordinators.
• Reviews protocol with principal investigator and other staff members to determine study feasibility.
• Provides appropriate documentation of study encounters, adverse events and concomitant medications in source document.
• Provides evidence-based nursing care consistent with the accepted professional standard related to their particular condition or therapy.
• Provides care and treatment that are consistent with the research protocol guiding their participation.
• Provides individualized treatment and monitoring to accommodate individual needs, to the extent allowed by the protocol, and that in all cases participant safety, comfort and well-being will be placed above research requirements. 
• Provides prompt assessment and appropriate response to changes in condition or untoward responses to research procedures. 
• Helps patients identify goals for treatment and study participation.
• Creates personal relationships with patients and ensure appropriate communication channels.
• Communicates and collaborates effectively with members of the clinical research team to assure coordinated