Clinical Research Coordinator - Internal Medicine (Nephrology)

Department

SOM KC Internal Medicine - Nephrology and Hypertension ----- Medicine - Nephrology and Hypertension

Position Title

Clinical Research Coordinator - Internal Medicine (Nephrology) Job Family Group: Professional Staff

Job Description

Summary: The Clinical Research Coordinator in the Department of Internal Medicine, Division of Nephrology works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the kidney transplant clinical research studies. This position oversees assigned studies, managing complex activities related to the collection, documentation, and analysis of clinical research data. Additionally, the Clinical Research Coordinator monitors participant progress, documents and reports adverse events, and participates in periodic quality assurance audits of study protocols.

Job Description

Job Duties Outlined Recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials under the direction of the principal investigator. Maintain 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. Assist clinical staff with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within institutional/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. 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. Work with the Research Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures. 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 position may occasionally require work outside of regular 8a-5p business hours. Coordinators will take a rotating call schedule for coverage. Required Experience Work Experience: 4 years of relevant work experience. Education may be substituted for experience on a year for year basis. 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. Preferred Experience Education: Bachelor’s degree in relevant field.