Research - Laboratory/Non-Laboratory, Staff/Administrative
The Cardiovascular Division is a growing, dynamic clinical research unit that supports the physician’s research portfolio in all sections of Cardiology including: Interventional, Heart Failure, Imaging, Vascular Disease, Structural Heart Disease, Prevention, and Electrophysiology to name a few. The Research Nurse Coordinator works closely with the investigators by coordinating complex clinical research projects, and is responsible for overall protocol management from start up to close out.
With guidance, this position is responsible to coordinate clinical research studies including nursing duties that are broad in nature as outlined in the protocol. Apply Knowledge of Good Clinical Practices and the Code of Federal Regulations to ensure compliance. This position requires excellent interpersonal and communication skills, attention to detail and organizational skills. This position requires the ability to work both independently and as part of a team, the ability to handle multiple projects and priorities to provide safe, quality care to research participants.
JOB RESPONSIBILITIES: 30% Provide clinical research assistance to University faculty performing clinical research. Follow GCP (Good Clinical Practice) guidelines in the conduct, performance and recording of clinical research.
Act as resource for protocol development and budget preparation.
Study start-up activities; site initiation visits, document template creation, study staff training, clinical in-services
Translate protocol required activities into flow sheets and patient care orders
In accordance with GCP and protocol, provide services, assessments, or interventions in accordance with all relevant policies, procedures and practice guidelines.
Provide initial protocol specific training for the study team, clinical settings, or medical departments where the clinical research will be performed.
Coordinate, delegate, and perform protocol specific assessments, including specialized and technical procedures defined by clinical trial protocol.
Act as a liaison between Principal Investigator, University departments, outside sponsors, clinical partners, and collaborators.
40% Manage or participate in subject recruitment, screening, consent, enrollment, and ongoing participation throughout the study.
Responsible for continuity of subject participation from beginning of clinical research study to the completion of study.
Identifies and assesses adverse events; responsible for subject protocol triage and symptom management.
Administers medications and treatments as required by protocol
Communicates significant changes in subject status with appropriate staff.
Interview subjects according to protocol specific visit requirements to include telephone follow-up, data collection and reporting.
Perform non-invasive protocol procedures, such as vital signs and EKG
Collect and process specimens or delegate appropriately (blood, urine, saliva)
30% Responsible for all regulatory aspects of the clinical trials as well as managing high-risk, highly-complex clinical trials.
Maintain accurate research records
Manage study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records and personal communications with other health care workers.
Oversee and maintain study/regulatory documentation (engaging with and/or delegating to others as needed)
Participates in production of research publications or presentation of research data.
Utilizes the nursing process and nursing standards to prevent or manage actual / potential research participants problems in all clinical care research settings
Educates staff, participants, and their families about protocols, treatment, possible side effects and complications
Delegate direct and indirect research activities to appropriate personnel based on needs, condition, and potential for risk/harm, complexity of the activity and predictability of the outcome.
Required Qualifications: (Must be documented in application materials) • BS degree in Nursing with at least 5 years of experience or a combination of related education and work experience to equal nine years; current license to practice as a Registered Nurse in the state of Minnesota. • Working knowledge of Microsoft Applications (Word, Excel) and web-based systems for tracking activities, and calendaring • Possess excellent communication skills; verbal and written • Flexibility with work schedule to accommodate participants visits.
Preferred Qualifications: • At least 2 years’ experience in a cardiovascular clinical setting and/or clinical research setting. • Familiarity with the University of Minnesota Medical Center-Fairview hospital and clinics. • Experience with clinical trials management systems and electronic regulatory binders • Experience in EPIC • Certified Clinical Research Coordinator or previous experience in clinical research. • Clinical research experience is preferred however, if you have experience in Cardiovascular and are a highly motivated individual looking to expand your career, we will train the right to person to join our team.
Internal Number: 340351
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.