Department:

SOM KC Internal Medicine - Gastroenterology and Hepatology

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Medicine-Gastroenterology

Position Title:

Clinical Research Coordinator - Internal Medicine (Gastro)

Job Family Group:

Professional Staff

Job Description Summary:

The Clinical Research Coordinator will work collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall coordination of clinical research studies. Responsibilities include managing clinical research studies by coordinating and participating in various complex activities such as collecting, compiling, documenting, and analyzing clinical research data. The role involves monitoring participants' progress, including documenting and reporting adverse events, and participating in periodic quality assurance audits of protocols.

Job Description:

Job Duties

• Under the guidance of the principal investigator, recruit, educate, and assess potential patients for eligibility in clinical trials.

• Management of biorepository.

• 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 the 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 the 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 role is fully on site.

Required Qualifications

Education: Associate’s degree or an equivalent combination of relevant post-secondary education and work experience that equals at least two years.

Work Experience:

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

• Solid understanding of regulations governing clinical research (CFR, GCP, HIPAA) as evidenced by application materials.

• Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research as evidenced by application materials.

• Experience with study budgets, contracts, and grant applications.

Preferred Qualifications

Work Experience:

• Experience working with multidisciplinary teams including physicians, and administrative staff.

Skills

• Excellent communication, writing, organizational, and presentation skills.

• Excellent organizational/multitasking skills.

• Excellent presentation and communication skills

• Excellent interpersonal skills and ability to effectively interact with multidisciplinary teams including, physicians, hospital, and administrative staff.

• Strong work ethic, detail oriented and ability to prioritize and meet deadlines.

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:

$58,656.00 - $86,000.00

Minimum

$58,656.00

Midpoint

$72,328.00

Maximum

$86,000.00