Clinical Research Nurse Coordinator - Cancer Center

University of Kansas Medical Center • Kansas City, KS

9h • Onsite

About The Position

The Clinical Research Nurse Coordinator in the Cancer Center 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 University of Kansas Cancer Center (KUCC) mission is to discover novel therapies and treatments for oncology patients. We are the region's only National Cancer Institute designated comprehensive cancer center where patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
Job Duties Outlined
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. 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. Support sample collection, processing, handling and shipping as outlined in the protocol, department expectations, and within institutional/KUMC policy. Coordinate study participant visit activities including scheduling procedures, communicating with participants. 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.

Requirements

• Must have RN license upon hire and throughout duration of employment.
• 2 years of related work experience.
• Relevant education may substitute on a year for year basis.
• Experience with regulations governing clinical research (CFR, GCP, HIPPA).
• Experience with statutes and guidelines relevant to regulatory affairs in clinical research.

Nice To Haves

• Bachelor of Science Nursing (RN-BSN)
• Oncology research experience.
• Certified Clinical Research Coordinator (CCRC).
• Certified Clinical Research Professional (CCRP).
• Healthcare certifications preferred such as Basic Life Support (BLS) or Advanced Cardiac Life Support (ACLS) within 3 months of employment.
• 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.
• 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.
• Support sample collection, processing, handling and shipping as outlined in the protocol, department expectations, and within institutional/KUMC policy.
• Coordinate study participant visit activities including scheduling procedures, communicating with participants.
• 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