Clinical Research Coordinator

Department :

SOM KC Division of Cardiovascular Diseases

CCR

Position Title :

Clinical Research Coordinator

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 :

Key Roles and Responsibilities

Under the direction of the Principal Investigator recruit and educate potential patients and evaluate potential patient eligibility for clinical trials.

Assess feasibility of research protocol including appropriate patient population budget and specific needs for the study.

Maintain source documents and submit case report forms (CRFs) as required for clinical trials. Completes and corrects case report forms ensuring accuracy of all records connected with each study with attention to medical events and concomitant medications as well as documentation for each study related event.

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.

Maintain current KURI-required education i.e. Human Subjects Protection HIPAA Adheres to GCP guidelines.

Assist clinical staff with phlebotomy and sample collection processing handling and shipping as outlined in the protocol and within institutional / KUMC policy.

Monitor awarded grants and contracts for compliance with performance reporting and accounting requirements.

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 Research Operations 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 all staff meetings as well as meetings both onsite and off-site as required by study. Serves as mentor for new staff members.

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 :

4 years prior research or related experience. Relevant education may be substituted for experience on a year for year basis.

Basic understanding of regulations governing clinical research (CFR GCP HIPAA).

Experience with statutes and guidelines relevant to regulatory affairs in clinical research.

Preferred Qualifications

Work Experience :

Cardiovascular research experience.

5 years or more research experience.

Experience using medical terminology.

Skills

Organization.

Communication.

Presentation skills.

Interpersonal skills.

Multi-tasking.

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. Type :

Regular

Time Type : Full time

Rate Type : Salary

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 :

$58656.00 - $86000.00

Minimum

$58656.00

Midpoint

$72328.00

Maximum

$86000.00

Required Experience :

IC

Key Skills

CSS,Cloud Computing,Health Education,Actuary,Building Electrician

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 58656 - 86000