Department:

SOM KC Kidney Institute (KI)

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Medicine - Nephrology and Hypertension

Position Title:

Clinical Research Coordinator - Internal Medicine (Nephrology)

Job Family Group:

Professional Staff

Job Description Summary:

The Renal Transplant Clinical Research Unit is looking for a candidate with Clinical Research experience to join their team. This position is responsible for working collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research.

The Clinical Research Coordinator will manage clinical research studies by coordinating and participating in a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Monitor participants’ progress including documenting and reporting adverse events. Participate in periodic quality assurance audits of protocols.

Job Description:

Job Duties Outlined

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

• Assesses 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.

• Maintains 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.

• 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 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 and Human Research Protection Program and have a working knowledge of KUMC policies and procedures.

• Attends 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.

Work Environment This position may require work over the weekend, nights, or holidays, depending on enrollment and transplant schedule. Coordinators will take a rotating call schedule for coverage. 

Required Qualifications

Education:

• Associate’s degree in healthcare related field or an equivalent combination of education and relevant work experience on a year for year basis.

Experience:

• Two years’ experience in health care, academic, and/or research experience.

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

• Basic understanding of statutes and guidelines relevant to regulatory affairs in clinical research.

• Experience and working knowledgeable of study budgets, contracts, and grant applications.

Preferred Qualifications

Education:

• Bachelor’s degree in health care related field, RN, or BSN.

Experience:

• 1 year or more clinical research experience highly preferred.

• Experience using medical terminology.

• Willingness to seek research certifications to further skills in the position.

Skills

• Excellent presentation, organizational and communication skills.

• Ability to effectively interact with multidisciplinary teams including physicians, administrative staff.

• Ability to recognize competing priorities and deadlines and seek guidance in management of these where needed.

• Strong work ethic, detail oriented, self- motivated and possess good interpersonal skills.

Required Documents

• Resume

• Cover Letter

Comprehensive Benefits Package:

Employee 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:

$58,000.00 - $86,000.00

Minimum

$58,000.00

Midpoint

$72,000.00

Maximum

$86,000.00