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

University of Kansas Medical Center • Kansas City, KS

22d • $65,000 - $99,000 • Onsite

About The Position

The Clinical Research Nurse Coordinator in the Diabetes Institute manages 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. This role monitors participant progress, including documenting and reporting adverse events, and participates in periodic quality assurance audits of study protocols. The position provides professional nursing care and patient monitoring for clinical trials and works collaboratively with multidisciplinary teams, research personnel, and hospital staff to recruit, screen, educate, and support participants throughout the clinical study coordination process. 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.

Requirements

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

Nice To Haves

• Bachelor of Science Nursing (RN-BSN)
• Certified Clinical Research Coordinator (CCRC) or certification eligible
• Certified Clinical Research Professional (CCRP) or certification eligible.
• Healthcare certifications preferred such as Basic Life Support (BLS) or Advanced Cardiac Life Support (ACLS) within 3 months of employment.
• Supervisory experience.
• Communication
• Presentation skills
• Organization
• Multitasking
• Interpersonal skills
• Time management

Responsibilities

• 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.
• 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.
• Recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials seeking guidance from Clinical Research Supervisor.
• 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.

Benefits

• Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
• Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available.
• Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays.
• One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment.
• A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees