Clinical Research Coordinator - Cancer Center; North Community Site

Clinical Research Coordinator - Cancer Center (North Community Site)

Department: SOM KC Cancer Center Clinical Trials, Clinical Trials Clinical Operations

Position Title: Clinical Research Coordinator - Cancer Center (North Community Site)

Job Family Group: Professional Staff

Job Description

Summary:

The 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. This position manages assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitors participants' progress including documenting and reporting adverse events.

Participates in periodic quality assurance audits of protocols.

The North Community site is located at: 8700 North Green Hills Rd. Kansas City, Missouri.

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.

• Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials.
• 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 clinical staff with phlebotomy and sample collection, processing, handling, and shipping as outlined in the protocol and within institutional/KUMC policy.
• Ensure adequate study supplies are being maintained. Track study expenditures 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.
• 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 Institute and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
• Attend continuing education, research and training seminars as requested by manager.

This position will be 100% onsite due to the fact this is a patient facing role.

• 4 years of relevant work experience. Education may be substituted for experience on a year for year basis.
• Experience with regulations governing clinical research (CFR, GCP, HIPAA).
• Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
• Experience study budgets, contracts, and grant applications.

Bachelor's degree.

• Certified Clinical Research Coordinator (CCRC)
• Certified Clinical Research Professional (CCRP)

• Communication.
• Organization.
• Multi-tasking.

The University of Kansas Medical Center is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, ethnicity, ancestry, age, protected veteran or disability status, marital status, parental status, or genetic information.