Senior Clinical Research Coordinator - Cancer Center

Job Duties

• Recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials.
• Absorb and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
• Assist clinical staff with study procedures, as outlined in the protocol and within state and KUMC scope of practice.
• Facilitate monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
• Prepare and maintain clinical trial contract documents and study budget reports.
• Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
• Assist clinical staff with sample collection, processing, handling, and shipping as outlined in the protocol and within 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.
• Attend continuing education, research and training seminars as requested by manager.
• 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.
• Carefully coordinate with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures.
• Review and assist with editing of new protocols. Assess feasibility of research protocol including appropriate patient population, budget and specific needs for the study.
• Assist Principal Investigators with internal and external funding application submissions.

Qualifications

• MUST have Research certification such as Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP).
• 8 years related work experience.
• Education may be substituted for education 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.