Nurse Clinician - Direct Care

Job Overview

This individual is a member of a research team, consulting with healthcare professionals and staff and providing direct research care coordination to patients/families. In this role, you will coordinate and execute research protocols in a clinical setting, utilizing Good Clinical Practice (GCP) and Human Subjects Research Protection standards.

• Coordinates research projects and clinical trials.
• Identifies potential study volunteers
• Consult with providers
• Manage research participant visits and follow up activities according to study protocol

Collects data and reports to Principal Investigator conducting study Analyze/evaluate data as needed for patient safety, protocol compliance and completion of study documentation Coordinates patient care as related to a specific research project or clinical trial

Location: UMMC West Bank Prof Bldg - 606 24th Ave S Minneapolis, Minnesota 55454

Schedule: 0.8

FTE (64 hours/2 weeks) Primarily within M-F 8:00AM-4:30PM. Flexibility to work outside of these hours as needed (but not regularly)

Performs research and clinical nursing duties that are broad in nature and may require design and development of data collection techniques and a thorough knowledge of the specialty, to include research compliance.

• Provide clinical research assistance to providers and constituents performing clinical research. Follow GCP (Good Clinical Practice) guidelines in the conduct, performance and recording of clinical research, support principal investigator (PI) compliance with same.
• Act as resource for protocol development and budget preparation.
• Basic level of understanding of CMS billing compliance regulations.
• Study start-up activities; site initiation visits, document template creation, study staff training, clinical in-services
• Oversee and maintain study/regulatory documentation (engaging with and/or delegating to others as needed)
• Translate protocol required activities into flow sheets and patient care orders
• Manage or participate in subject recruitment, screening, consent, enrollment, and necessary registrations (EMR)
• Responsible for continuity of subject participation from beginning of clinical research study to the completion of study.
• 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.
• Interview subjects according to protocol specific visit requirements to include telephone follow-up, data collection and reporting.
• Perform non-invasive protocol procedures, as applicable
• Collect and process specimens or delegate appropriately (blood, urine, saliva)
• 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, subjects, and their families about protocols, treatment, possible side effects and complications
• May provide patient care for research patients
• 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.
• Report all work time on the monthly tracking document and update Subject Tracking Forms in the organization's business systems and clinical trial management systems.
• In accordance with GCP and protocol, provide services, assessments, or interventions in accordance with all relevant policies, procedures and practice guidelines.
• 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.

Communicates with constituents and customers about cardiovascular sponsored clinical trials and their processes.

• Ensures that IRB committee recommendations are communicated to sponsors and staff and implemented in a timely and effective manner.
• Communicates with sponsor regarding patient consent forms, approval letters and other required forms
• Maintains communications with research staff, IRB, IDS Pharmacy, Fairview Research Administration and sponsors on the status of studies.

• Associate degree from an accredited school of nursing
• MN Registered Nurse (RN) License
• Two years’ experience in a research setting or two years’ clinical experience in rare disease populations

• Bachelor’s degree in nursing or health-related scientific field of study
• Two years’ experience within rare disease research

Fairview offers a generous benefit package including but not limited to medical, dental, vision plans, life insurance, short-term and long-term disability insurance, PTO and Sick and Safe Time, tuition reimbursement, retirement, early access to earned wages, and more! Please follow this link for additional…