Clinical Research Coordinator- Cardiology

Department: SOM KC Division of Cardiovascular Diseases - CCR

Job Description Summary: The Clinical Research Coordinator in the department of Cardiology works collaboratively with multidisciplinary teams, research, and hospital staff in the overall clinical study coordination of clinical research. This position coordinates assigned clinical research studies across a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Supports regulatory and study compliance.

Job Responsibilities

Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials.
Develop and 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 with sample collection, processing, handling, and shipping as outlined in the protocol, department expectations, and within institutional/KUMC policy.
Ensure adequate study supplies are being maintained. Track and document study visits in the Clinical Trials Management System, study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
Maintain trial regulatory documentation files as directed, including correspondence with sponsor, IRB, departmental support and participants.
Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and other team members, as required.
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 closely with the Research Administration, Department Administrators and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
Participate in continuing education, research and training.
Coordinate study participant visit activities including scheduling procedures, communicating with participants.
Assist feasibility assessment of research protocol including appropriate patient population, budget and specific needs for the study.
Report out study budgets, contracts, and grant applications throughout the Lifecyle of the study.
Support the development of study budgets, contracts, grant applications and study documents for start-up and throughout the lifecycle of the study.
This role will mentor Clinical Research Assistants.

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Clinical Research Coordinator- Cardiology

University of Kansas Medical Center

2120 W 36 Ave, Kansas City, KS 66103, USA