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Medicine - Nephrology and HypertensionJob Duties Outlined
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.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Work Environment: This position may occasionally require work outside of regular 8a-5p business hours. Coordinators will take a rotating call schedule for coverage.
Required Experience:
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)
Preferred Experience:
Education: Master’s degree in relevant field.
Skills
Organization
Communication
Problem-solving
Time-management skills
Required Documents
Resume/CV
Cover Letter
Comprehensive Benefits Package:
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. https://www.kumc.edu/human-resources/benefits.html
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
Minimum
$70,200.00Midpoint
$87,700.00Maximum
$105,300.00