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rClinical Research Nurse Coordinator - Internal Medicine (Endocrinology, Diabetes & Clinical Pharmacology)

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Department:

SOM KC The Diabetes Institute (DI)

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Diabetes Institute

Position Title:

Clinical Research Nurse Coordinator - Internal Medicine (Endocrinology, Diabetes & Clinical Pharmacology)

Job Family Group:

Professional Staff

Job Description Summary:

The Clinical Research Nurse Coordinator will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data with the division of Internal Medicine - Diabetes Institute. Monitor participants\' progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols. This position provides professional nursing care and patient monitoring for clinical trials. Responsible for working collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research.

The KU Diabetes Institute\'s mission is to advance research leading toward prevention and control of diabetes, as well as an eventual cure for the disease. Researchers and clinicians from the University of Kansas Medical Center, the University of Kansas-Lawrence, and the KU School of Medicine-Wichita form the core of the Institute and are engaged in a wide range of basic science, translational and clinical research projects centering around diabetes and its complications.

Job Description:

Job Duties

• Plan, provide, and document professional nursing care utilizing the nursing process for patients in accordance with physician orders, institutional SOPs, and state licensure scope of practice. Use professional nursing judgment when conducting nursing research activities to participants.
• Assure that all professional nursing care provided is conducted in accordance with all KUMC and other regulatory requirements and is in accordance with the scope of practice for the nursing license held.
• Under the direction of Principal Investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials seeking guidance from Clinical Research Nurse Sr.
• Assist clinical staff with maintaining source documents and submit case report forms (CRFs) as required for clinical trials.
• Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
• Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
• Perform phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within KUMC policy.
• Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies, and study participants.
• Prepare documentation and participate in study monitoring visits, reviews, and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
• Attend continuing education, research and training seminars as requested by manager.
• Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria, and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
• This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.

Work Environment: This role will be fully on-site.

Required Qualifications

Education: Associate\'s degree or relevant experience may be substituted on a year-to-year basis.

Certifications/Licenses: RN state licensure

Work Experience:

• 2 years of related work experience
• Advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA)
• Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
• Experience with study budgets, contracts, and grant applications.

Preferred Qualifications

Education: Bachelor of Science Nursing (RN-BSN)

Certifications:

Certified Clinical Research Coordinator (CCRC) or certification eligible

Certified Clinical Research Professional (CCRP) or certification eligible.

Healthcare certifications preferred such as B