Clinical Research Assistant - Cancer Center

Department: SOM KC Cancer Center Clinical Trials Clinical Program Management

Job Description Summary: The Clinical Research Assistant assists in entry level clinical research activities including collecting information from patients/study participants and families. This position provides physicians, administrative staff, sponsors and CRO representatives with requested information and support.

The University of Kansas Cancer Center is the only National Cancer Institute designated Comprehensive Cancer Center in the region, 1 of only 57 in the nation to receive this distinction. Patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.

Job Duties Outlined

Under the direction of the principal investigator, may assist in recruitment, evaluation, and education of patients regarding clinical trials following established procedures and protocols.
Develop and maintain source documents and submit case report forms (CRFs) as required for clinical trials.
Ensure activities are conducted in a professional and ethical manner, and in accordance with KUMC Policies and applicable local, state and federal laws and regulations.
Perform job responsibilities in a safe and secure manner.
Ensure coordination of area work with other areas of KUMC to ensure integration and support of KUMC goals and objectives.
Develop, maintain and expand job-specific knowledge and skills to keep pace with industry changes and support the university's commitment to excellence and innovation.
May participate in relevant committees, task force, or other similar activities.
Maintain confidentiality of medical center, employee, and patient information. Handle sensitive data with discretion and in accordance with KUMC policies and legal requirements.
Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
May perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
Ensure adequate study supplies are being maintained. May 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.
May 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.
May 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.
May coordinate study participant visit activities including scheduling procedures, communicating with participants.

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Clinical Research Assistant - Cancer Center

University of Kansas Medical Center

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