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University of Kansas Medical Center

Health sciences campus in Kansas City, KS

Clinical Research Coordinator - Multiple Teams

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeKansas, USA$60.8k - $91.2k

About the Job

Requirements

  • Four years of experience in health sciences, nursing, biology, or a related field; education may be substituted for experience on a year-for-year basis.
  • Two years of clinical research experience.
  • Experience with clinical research regulations, including the Food and Drug Administration, Good Clinical Practice, Institutional Review Board, and Health Insurance Portability and Accountability Act requirements.
  • Phlebotomy certification is preferred.
  • Four years of clinical research experience is preferred.
  • Experience in pulmonary, critical care, or sleep medicine research is preferred.
  • Experience with REDCap, Epic, or similar data management systems is preferred.
  • Organization, problem-solving, communication, and computer skills.
  • Evening hours may occasionally be required.

Responsibilities

  • Coordinate multiple clinical research studies, including investigator-initiated and industry-sponsored trials.
  • Develop and maintain study-specific documents, including regulatory binders, case report forms, and data collection tools.
  • Ensure research protocols are conducted in accordance with Institutional Review Board, Food and Drug Administration, National Institutes of Health, and institutional regulations.
  • Monitor study progress, ensuring adherence to timelines and compliance with protocols.
  • Identify and screen eligible participants for clinical studies based on protocol inclusion and exclusion criteria.
  • Obtain informed consent and educate participants about study procedures, risks, and benefits.
  • Schedule study visits and follow-ups, and coordinate necessary clinical assessments.
  • Collect and enter accurate research data into electronic data capture systems.
  • Maintain compliance with Good Clinical Practice and institutional policies.
  • Prepare and submit regulatory documents to Institutional Review Boards and sponsor organizations.
  • Assist in audits and monitoring visits, and respond to queries from regulatory agencies.
  • Coordinate sample collection, processing, and shipping according to study requirements.
  • Assist with study-related procedures, such as pulmonary function tests, sleep studies, and vital sign monitoring, under supervision.
  • Ensure investigational products, including drugs and devices, are handled according to protocol and regulatory requirements.
  • Act as a liaison between study sponsors, investigators, patients, and healthcare providers.
  • Participate in research team meetings, sponsor calls, and professional development sessions.
  • Provide education and training to new research personnel and clinical staff as needed.

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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