The Knight Cardiovascular Institute (KCVI) is recognized as a top integrated center for cardiovascular clinical care, translational research and professional training in all aspects of heart and vascular disease. Guided by a multi-disciplinary approach, researchers and clinicians drive a vibrant translational research program, which focuses on delivering the latest knowledge and cutting edge care to patients. Specifically, research at KCVI seeks to improve patient outcomes by achieving earlier diagnosis of disease, more accurate monitoring of its progression, and tailoring therapy to the molecular basis of disease.

 

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.

 

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, high quality care. 
• Ensures that information about their patient’s care and condition is discussed and communicated with confidentiality, and that care is being appropriately documented. 
• Ensures that, while at the Knight Cardiovascular Institute, the patient will have a sense of being cared for as an individual, and that they will receive prompt, courteous, and individualized services from nurses and patient care staff. 
• Empowers and helps the patient to develop an understanding of their condition, research participation and treatment, and be able to manage self-care as appropriate after treatment is completed. 
• Involves the patient with discussions and decisions about their plan of care and research participation. 

Administrative Responsibilities: 

• Attends study initiation meetings
• Attends monitor visits, as needed
• Billing schedule review 
• Assists with FDA inspections
• Assists with query resolution
• SAE grading and documentation
• Other assigned duties 

Process Improvement: 

• Identifies opportunities for and implements process improvements, in collaboration with others within the Knight Cardiovascular Institute within the department of Cardiology. 

Training/Mentoring of staff members:

• Mentors clinical research staff members, as assigned
• Participates in mentoring program of affiliate site Research Nurse shadowing at OHSU as applicable. 

• BSN AND 5 years recent nursing clinical experience OR Masters Degree and 3 years of experience AND independent Judgement & Responsibility

• BLS required

• Ability to prioritize multiple tasks at one time

• Excellent communication, analytical and organizational skills: both written and verbal

• Ability to work independently and as part of a team while being collaborative in resolving problems

• Deep knowledge and experience with FDA, ICH GCP and other regulatory guidelines that govern clinical research

• Strong understanding of clinical research requirements with regard to staffing, systems and processes

• Strong ability to set appropriate priorities and manage time

• Ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment

• Solution-oriented approach to issues

• Proficiency with computers running Windows and PC applications e.g. MS Excel, Oracle, Access, Word and PowerPoint

• Excellent customer service skills, both on the phone and in person

• Energy and drive to coordinate multiple projects simultaneously

• Ability to use tact and diplomacy to maintain effective working relationships

• Active RN license in the state of Oregon; Basic Life Support Certification

• BSN/MSN
• 2+ years of clinical trial research experience as a Clinical Research Coordinator or Research Nurse

• Familiarization with the Code of Federal Regulations and GCP guidelines governing the conduct of clinical trials

• Ability to read investigational product protocols

• Proficient experience using Epic EHR

• Research certification (SoCRA, ACRP)

• Typical schedule: Monday - Friday, occasional nights and weekends, and international, national, local travel
• Work schedule may vary depending on job/study requirements
• Travel between meeting locations
• May have exposure to human tissues, fluids, radiation
• May have regular exposure to noise and interruptions

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.