Clinical Research Coordinator - Cardiology

Department:

SOM KC Cardiovascular Medicine

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CCR

Position Title:

Clinical Research Coordinator - Cardiology

Job Family Group:

Professional Staff

Job Description Summary:

The 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. 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.

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.

• 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.

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:

• Four years related work experience relevant education may substitute 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.

Preferred Qualifications

Education: Bachelor’s degree in relevant field.

Certifications/Licenses: Research certification preferred such as:

• Certified Clinical Research Coordinator (CCRC) or certification eligible

• Certified Clinical Research Professional (CCRP) or certification eligible

Skills

• Communication.

• Presentation skills.

• Organization.

• Interpersonal skills.

• Time management.

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 gen