Senior Clinical Research Coordinator - Cancer Center

University of Kansas Medical Center • Kansas City, MO

1d • Onsite

About The Position

The Senior 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. The Senior Clinical Research Coordinator will manage assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Participates in periodic quality assurance audits of protocols. Supports the development of study budgets, contracts, and grant applications. Provides task direction, as needed, for junior level clinical research coordinators. 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.

Requirements

• 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.

Nice To Haves

• Master's degree
• Communication
• Presentation skills
• Organization
• Time management skills
• Computer skills

Responsibilities

• Under the direction of the principal investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials.
• Assist clinical staff with maintaining source documents and submit case report forms (CRFs) as required for clinical trials.
• Responsible for lead worker duties including mentoring, training and assisting junior staff with onboarding and learning the clinical research coordinator position.
• Recognize 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.
• Coordinate closely 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.
• Assesses 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.

Benefits

• health, dental, and vision insurance
• health expense accounts with generous employer contributions
• Employer-paid life insurance
• long-term disability insurance
• various additional voluntary insurance plans
• Paid time off, including vacation and sick
• ten paid holidays
• One paid discretionary day is available after six months of employment
• paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment
• A retirement program with a generous employer contribution
• additional voluntary retirement programs (457 or 403b)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior