Title: Clinical Research Coordinator
Company: University of Kansas Medical Center
Location: Kansas City, KS
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.
• 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.
• Other relevant duties as requested by the supervisor.
• Associate’s degree plus two years related work experience OR an equivalent combination of relevant post-secondary education and work experience that equals at least 4 years.
• Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA).
• Basic understanding of statutes and guidelines relevant to regulatory affairs in clinical research. Knowledgeable of study budgets, contracts and grant applications.
• Excellent communication, writing, organizational and presentation skills.
• Ability to effectively interact with multidisciplinary teams including physicians, administrative staff.
• Ability to recognize competing priorities and deadlines and seek guidance in management of these where needed.
• To learn more about this and other opportunities for Clinical Research Coordinators click "Apply Online" below and search for position number JR000536
Min: $50,589 Mid: $64,386 Max: $78,183
SOCRA Exp: 3/8/2021