This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13061533

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rClinical Research Nurse Coordinator Internal Medicine (Pulmonary)

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Department:

SOM KC Internal Medicine - Pulmonary, Critical Care, and Sleep Medicine

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Pulmonary and Critical Care Medicine

Position Title:

Clinical Research Nurse Coordinator - Internal Medicine (Pulmonary)

Job Family Group:

Professional Staff

Job Description Summary:

The Clinical Research Nurse Coordinator provides professional nursing care and patient monitoring for clinical trial participants. Works collaboratively with multidisciplinary teams, research and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of less complex clinical research. Conduct a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors participant\'s progress including documenting and reporting adverse events. Participates in periodic quality assurance audits of protocols.

Job Description:

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. 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 the 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 Basic Life Support (BLS) or Advanced Cardiac Life Support (ACLS) within 3 months of employment.

Work Experience:

• Prior supervisory experience.

Skills

• Excellent communication, writing, organizational and presentation skills.
• Excellent organizational/multitasking skills.
• Ability to fully contribute to multidisciplinary teams including physicians, administrative staff to assure that the goals and objectives of the program or project are met.
• Ability to effectively manage competing priorities and deadlines.

Required Documents