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University of Kansas Medical Center Senior Clinical Research Coordinator in Wichita, Kansas

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/ada/r/jobs/11393441 Senior Clinical Research CoordinatorDepartment:SHP Physical Therapy & Rehab Science (PTRS)-----Research in Exercise and Cardiovascular Health LaboratoryPosition Title:Senior Clinical Research CoordinatorJob Family Group:Professional StaffJob Description Summary:This posting is for a Senior Clinical Research Coordinator in the Research in Exercise and Cardiovascular Health (REACH) Laboratory under Sandra Billinger, PhD, PT. The studies in the laboratory are lifestyle/exercise interventions along with clinical research trials. Our dynamic team collaborates across our institution with the KU Alzheimer's Disease Center, the stroke research team, Hoglund Biomedical Imaging Center and the CTSU. We are involved in several multisite NIH-funded trials.The Senior Clinical Research Coordinator works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research.The Senior Clinical Research Coordinator will manage assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Participates in periodic quality assurance audits of protocols. Supports the development of study budgets, contracts, and grant applications. Provides task direction, as needed, for junior level clinical research coordinators and research assistants.Job Description:Required Qualifications: Associate's degree plus six years related work experience OR an equivalent combination of relevant post secondary education and work experience that equals at least 8 years. Advanced understanding of regulations governing clinical research (CFR, GCP, HIPAA) Advanced understanding of statutes and guidelines relevant to regulatory affairs in clinical research. In-depth knowledge of study budgets, contracts and grant applications. Excellent communication, writing, organizational and presentation skills. Ability to fully contribute to multidisciplinary teams including physicians, administrative staff. Ability to effectively manage competing priorities and deadlines. Research certification required such as:- Certified Clinical Research Coordinator (CCRC) or certification eligible- Certified Clinical Research Professional (CCRP) or certification eligiblePreferred Qualifications: Business and financial acumen to assist in developing study budgets, contracts and grant applications. Master's degree in relevant field.Job Duties Outlined: Under the direction of the Principal Investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials. 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. Assist clinical staff with study procedures, as outlined in the protocol and within state and KUMC scope of practice. As requested, facilitate monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required. Prepare and maintain clinical trial contract documents and study budget reports. 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 KUMC policy. Ensure adequate study supplies are being maintained. Track study e xpenditures 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. Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures. Reviews and assists with editing of new protocols. Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study. Assist Principal Investigators with internal and external funding application submissions. Other relevant duties as requested by the supervisor.Required Documents: Resume/CV Cover Letter 3 referencesEmployee Type:RegularTime Type:Full timePay Rate Type:SalaryPay Grade:A12Pay Range:Minimum57572Midpoint73650Maximum89210Application Instructions:To learn more and apply on

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