Clinical Research Nurse Coordinator Internal Medicine Position
1 week ago
The University of Kansas Medical Center is seeking a skilled Clinical Research Nurse Coordinator to join our team in the Department of Internal Medicine - Pulmonary, Critical Care, and Sleep Medicine. This role will be responsible for providing professional nursing care and patient monitoring for clinical trial participants, working collaboratively with multidisciplinary teams to recruit, screen, educate, and assist in the overall clinical study coordination of less complex clinical research.
Key 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.
- 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.
- 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.
- 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.
- 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.
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