Senior Clinical Research Coordinator - Internal Medicine (Nephrology)

University of Kansas Medical Center • Kansas City, MO

5d

About The Position

The Senior Clinical Research Coordinator in the Department of Internal Medicine, Division of Nephrology works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the kidney transplant clinical research studies. The Senior Clinical Research Coordinator manages assigned studies, overseeing complex activities related to the collection, documentation, and analysis of clinical research data. This role participates in periodic quality assurance audits, supports the development of study budgets, contracts, and grant applications, and provides task direction as needed to other clinical research staff.

Requirements

• Work Experience: 8 years related 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 with study budgets, contracts, and grant applications.
• Certifications: At least one of the following: Certified Clinical Research Coordinator (CCRC) Certified Clinical Research Professional (CCRP)
• Skills Organization
• Communication
• Problem-solving
• Time-management skills
• Resume/CV
• Cover Letter

Nice To Haves

• Education: Master’s degree in relevant field.

Responsibilities

• Recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials under the direction of the principal investigator.
• Assist clinical staff with maintaining 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.
• 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.
• 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 phlebotomy and 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.
• 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 with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures.
• Reviews and assists 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

• Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan.
• Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available.
• Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays.
• One paid discretionary day is available after six months of employment, and 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 and additional voluntary retirement programs (457 or 403b) are available.

What This Job Offers

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