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CCRPosition Title:Clinical Research Coordinator- CardiologyJob Family Group: Professional StaffJob Description Summary:The Clinical Research Coordinator in the department of Cardiology works collaboratively with multidisciplinary teams, research, and hospital staff in the overall clinical study coordination of clinical research. This position coordinates assigned clinical research studies across a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Supports regulatory and study compliance.Job Description:Job Responsibilities
Under the direction of the principal investigator, recruit and educate potential patients for and evaluate potential patient eligibility for clinical trials.
Develop and 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 with sample collection, processing, handling, and shipping as outlined in the protocol, department expectations, and within institutional/KUMC policy.
Ensure adequate study supplies are being maintained. Track and document study visits in the Clinical Trials Management System, study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
Maintain trial regulatory documentation files as directed, including correspondence with sponsor, IRB, departmental support and participants.
Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and other team members, 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 Administration, Department Administrators and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.
Participate in continuing education, research and training.
Coordinate study participant visit activities including scheduling procedures, communicating with participants.
Assist feasibility assessment of research protocol including appropriate patient population, budget and specific needs for the study.
Report out study budgets, contracts, and grant applications throughout the Lifecyle of the study.
Support the development of study budgets, contracts, grant applications and study documents for start-up and throughout the lifecycle of the study.
This role will mentor Clinical Research Assistants.
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.
Required Qualifications
Work Experience:
Six years of work experience in healthcare or research setting.
Experience with clinical research regulations (FDA, GCP, IRB, HIPAA).
Experience with study budgets, contracts and/or grant applications.
Preferred Qualifications
Education: Bachelor’s degree in relevant field like health sciences, biology, nursing, or a related field. Experience may be substituted for education on a year for year basis.
Certifications:
Certified Clinical Research Coordinator (CCRC) or
Certified Clinical Research Professional (CCRP) or
Association of Clinical Research Professionals (ACRP)
Skills
Communication skills.
Computer skills.
Self-initiative.
Organization.
Detail-Oriented.
Time management.
Prioritization.
Delegation.
Required Documents
Resume
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.
Pay Range:$60,800.00 - $91,200.00Minimum
$60,800.00Midpoint
$76,000.00Maximum
$91,200.00Similar Jobs
What We Do
The University of Kansas Medical Center is an academic health center that includes a hospital and research institute, dedicated to patient care, medical research, and education.
