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University of Kansas Medical Center

Health sciences campus in Kansas City, KS

Clinical Research Coordinator: Cardiology

Clinical Research OperationsPosted on Nov 13
Full-timeKansas City Metropolitan Area, USA$60.8k - $91.2kIn-person

About the Job

Requirements

  • Six years of work experience in a healthcare or research setting; experience may substitute for education on a year-for-year basis.
  • Experience working in an environment requiring an understanding of regulations governing clinical research, including CFR, GCP, HIPAA, and statutes and guidelines relevant to regulatory affairs in clinical research.
  • Experience with study budgets, contracts, and grant applications.
  • Bachelor’s degree in a relevant field such as health sciences, biology, nursing, or a related field is preferred.
  • Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP), or Association of Clinical Research Professionals (ACRP) certification is preferred.
  • Communication, organization, attention to detail, time management, prioritization, delegation, and computer skills.

Responsibilities

  • Recruit and educate potential clinical-trial participants and evaluate their eligibility under the direction of the principal investigator.
  • Develop and maintain source documents and submit case report forms (CRFs) as required for clinical trials.
  • Recognize and report adverse events and 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 with sample collection, processing, handling, and shipping as outlined in the protocol, department expectations, and policy.
  • Maintain study supplies; track and document study visits in the Clinical Trials Management System; track study expenditures; and submit reimbursement requests for study equipment, supplies, and participants.
  • Maintain trial regulatory documentation files as directed, including correspondence with the sponsor, IRB, departmental support, and participants.
  • Prepare documentation for and participate in study monitoring visits, reviews, and audits; provide written and verbal reports to the principal investigator and other team members as required.
  • Participate in quality assurance by reviewing clinical data in medical-record charts, assessing pharmacy compliance with protocol criteria, and reviewing study documentation for compliance with GCP guidelines and FDA CFR.
  • Work with Research Administration, Department Administrators, and the Human Research Protection Program, maintaining working knowledge of KUMC policies and procedures.
  • Participate in continuing education, research, and training.
  • Coordinate study-participant visit activities, including scheduling procedures and communicating with participants.
  • Assist with feasibility assessments of research protocols, including the appropriate participant population, budget, and specific study needs.
  • Report on study budgets, contracts, and grant applications throughout the study lifecycle.
  • Support development of study budgets, contracts, grant applications, and study documents for start-up and throughout the study lifecycle.
  • Mentor Clinical Research Assistants.

About the Company

University of Kansas Medical Center

Health sciences campus in Kansas City, KS

University of Kansas Medical Center is the University of Kansas academic health sciences campus in Kansas City, Kansas. Its schools provide degree-granting education in health professions, medicine, and nursing.

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